An antidepressant is a psychiatric medication used to alleviate mood disorders, such as major depression and dysthymia and anxiety disorders such as social anxiety disorder. According to Gelder, Mayou &*Geddes (2005) people with a depressive illness will experience a therapeutic effect to their mood; however, this will not be experienced in healthy individuals. Drugs including the monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), tetracyclic antidepressants (TeCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine reuptake inhibitors (SNRIs) are most commonly associated with the term. These medications are among those most commonly prescribed by psychiatrists and other physicians, and their effectiveness and adverse effects are the subject of many studies and competing claims. Many drugs produce an antidepressant effect, but restrictions on their use have caused controversy and off-label prescription is a risk, despite claims of superior efficacy.

Opioids were used to treat major depression until the late 1950s. Amphetamines were used until the mid 1960s. Prescribing opioids or amphetamines for depression falls into a legal grey area. Research has only rarely been conducted into the therapeutic potential of opioid derivatives for depression in the past sixty years, whereas amphetamines have found a thriving market for conditions as widely arrayed as attention deficit disorder, narcolepsy, and obesity, and continue to be studied for myriad applications. Both opioids and amphetamines induce a therapeutic response very quickly, showing results within twenty-four to forty-eight hours; the therapeutic ratios for both opioids and amphetamines are greater than those of the tricyclic anti-depressants. In some of this little, heavily restricted research, the opioid buprenorphine has shown the greatest potential for treating severe, treatment-resistant depression of any known pharmaceutical in a small study that is generally recognized and was published in 1995, but has never been pursued due to the social stigma attached to opioids in addition to that attached to mental illness in America.

Most typical antidepressants have a delayed onset of action (2–6 weeks) and are usually administered for anywhere from months to years. Despite the name, antidepressants are often used controversially, and with a dearth of empirical evidence to support their indication, off-label to treat other conditions, such as anxiety disorders, obsessive compulsive disorder, eating disorders, chronic pain, and some hormone-mediated disorders such as dysmenorrhea. Alone or together with anticonvulsants (e.g., Tegretol or Depakote), these medications can be used to treat attention-deficit hyperactivity disorder (ADHD) and substance abuse by addressing underlying depression. Also, antidepressants have been used sometimes to treat snoring and migraines.

Other medications that are not usually called antidepressants, including antipsychotics in low doses and benzodiazepines,  may be used to manage depression, although benzodiazepines cause a physical dependence to form. Stopping benzodiazepine treatment abruptly can cause unpleasant withdrawal symptoms. An extract of the herb St John’s Wort is commonly used as an antidepressant, although it is labeled as a dietary supplement in some countries. The term antidepressant is sometimes applied to any therapy (e.g., psychotherapy, electro-convulsive therapy, acupuncture) or process (e.g., sleep disruption, increased light levels, regular exercise) found to improve a clinically depressed mood.

Inert placebos can have significant antidepressant effects, and so to establish a substance as an “antidepressant” in a clinical trial it is necessary to show superior efficacy to placebo. A review of both published and unpublished trials submitted to the U.S. Food and Drug Administration (FDA) found that the published trials had a 94% success in treating depression while the unpublished literature had below 50% success. Combined, all studies showed 51% efficacy – only two points better than that of placebo. The difference in effect between active placebos and several anti-depressants appeared small and strongly affected by publication bias. There is some evidence to suggest that mirtazapine and venlafaxine may have greater efficacy than other antidepressants in the treatment of severe depression.

Source: http://en.wikipedia.org/wiki/Antidepressant

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Selective serotonin reuptake inhibitors (SSRIs) are a class of antidepressants considered the current standard of drug treatment. A possible cause of depression is an inadequate amount of serotonin, a chemical used in the brain to transmit signals between neurons. SSRIs are said to work by preventing the reuptake of serotonin (also known as 5-hydroxytryptamine, or 5-HT) by the presynaptic neuron, thus maintaining higher levels of 5-HT in the synapse. Chemists Klaus Schmiegel and Bryan Molloy of Eli Lilly discovered the first SSRI, fluoxetine. This class of drugs includes:
Citalopram (Celexa, Cipramil)
Escitalopram (Lexapro, Cipralex, Seroplex, Lexamil)
Fluoxetine (Prozac, Sarafem, Symbyax)
Fluvoxamine (Luvox)
Paroxetine (Paxil, Aropax)
Sertraline (Zoloft)
Vilazodone (Viibryd)

These antidepressants typically have fewer adverse effects than the tricyclics or the MAOIs, although such effects as drowsiness, dry mouth, nervousness, anxiety, insomnia, decreased appetite, long-term weight gain and decreased ability to function sexually may occur. Some side effects may decrease as a person adjusts to the drug, but other side effects may be persistent.

Work by two researchers has called into question the link between serotonin deficiency and symptoms of depression, noting that the efficacy of SSRIs as treatment does not in itself prove the link. Research indicates that these drugs may interact with transcription factors known as “clock genes”, which may play a role in the addictive properties of drugs (drug abuse), and possibly in obesity.

A systematic review of randomized controlled trials published in the Archives of General Psychiatry showed that up to one-third of the 6-week effect of SSRI Treatment can be seen in the first week. The same study also found that patients treated with SSRIs were 64% more likely to achieve a 50% absolute reduction in HRSD than patients given a placebo.[1]

Citalopram (Celexa): usual dosing is 20 mg initially; maintenance 40 mg per day; maximum dose 60 mg per day.
Escitalopram (Lexapro, Cipralex): usual dosing is 10 mg and shown to be as effective as 20 mg in most cases. Maximum dose 20 mg. Also helps with anxiety.
Paroxetine (Paxil, Seroxat): Also used to treat panic disorder, OCD, social anxiety disorder, generalized anxiety disorder and PTSD. Usual dose 25 mg per day; may be increased to 40 mg per day. Available in controlled release 12.5 to 37.5 mg per day; controlled release dose maximum 50 mg per day. Less cycling in patients who are bipolar.
Fluoxetine (Prozac): Also used to treat OCD, bulimia, and panic disorder. Long half-life; less withdrawal when medication is stopped. Dosing is 20 mg to a maximum of 80 mg.
Fluvoxamine (Luvox): Although primarily used in the treatment of OCD, a doctor may prescribe it for depression. Initial dose is 50 mg, increasing by 50 mg every 4-7 days. If daily dose is greater than 100 mg give in equally divided doses or give larger dose at bedtime not to exceed 300 mg per day.
Sertraline (Zoloft, Lustral): Also used to treat panic disorder, OCD, PTSD, social anxiety disorder, premenstrual dysphoric disorder. Dosing is 50-200 mg per day and should be titrated upward.

Be aware of drug interactions. Dextromethorphan (found in many brands of over-the-counter cough syrup) as well as the opioids tramadol (Tramal, Ultram), and pethidine/meperidine are contraindicated with all SSRIs as they are serotonin reuptake inhibitors (SRIs) themselves and the combination could cause the potentially fatal serotonin syndrome. Many SSRIs inhibit the metabolism of dextromethorphan as well, further adding to the risk.

Drug interactions may also occur when concurrently taking phenytoin (Dilantin) and warfarin (Coumadin) (phenytoin and warfarin levels are increased).

Always check with pharmacy regarding potential drug interactions.[2]

Source:

[1]http://en.wikipedia.org/wiki/Antidepressant

[2]http://en.wikipedia.org/wiki/List_of_antidepressants

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Safety Announcement

[07-26-2011] The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications). Methylene blue is commonly used in diagnostic procedures and is also used to treat a number of medical conditions (see Facts about methylene blue box). A list of the serotonergic psychiatric medications that can interact with methylene blue can be found here.

Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.

Healthcare professionals and patients may not realize that methylene blue has monoamine oxidase inhibitor (MAOI) properties. Methylene blue should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with methylene blue such as when it is used in the emergency treatment of:
methemoglobinemia,
ifosfamide-induced encephalopathy, or
cyanide poisoning.

Safety information about these potential drug interactions and important drug usage recommendations for emergency and non-emergency situations are being added to the drug labels for serotonergic psychiatric medications. (See Additional Information for Healthcare Professionals)

A separate Drug Safety Communication (DSC) is being released today for linezolid (Zyvox) due to similar potential drug interactions with serotonergic psychiatric medications and includes drug usage recommendations.

Health Canada issued a NOTICE TO HOSPITALS on the association of serotonin toxicity with methylene blue in combination with serotonin reuptake inhibitors on February 16, 2011.

Additional Information for Patients
You may need to temporarily stop taking your serotonergic psychiatric medication if it becomes necessary for you to take methylene blue in certain situations. Your healthcare provider will tell you when to start methylene blue after stopping your serotonergic psychiatric medication.
Do not stop taking your serotonergic psychiatric medicine without first talking to a healthcare professional.
Make sure your healthcare professional knows about all the medications you are taking. It is helpful to keep a list of all your current medications in your wallet or another location where it is easily retrieved.
Contact your healthcare professional immediately if you are taking a serotonergic psychiatric medication and develop any of the following symptoms: mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.
Discuss any questions or concerns about methylene blue or serotonergic psychiatric medications with your healthcare professional.
Report any serious side effects you experience to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals
Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity.
In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity. If methylene blue must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first.
In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate. Most serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance.
Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue.
Serotonergic psychiatric medications should not be started in a patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant.
Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.
Report adverse events involving methylene blue or serotonergic psychiatric medications to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Data Summary

FDA has received adverse event reports from the FDA Adverse Event Reporting System (AERS) database of serious central nervous system (CNS) reactions in patients treated with serotonergic psychiatric medications who were administered methylene blue. Additional cases also have been reported in the published literature.1-3 The reported adverse events include the following: lethargy, confusion, delirium, agitation, aggression, obtundation, and coma. These symptoms were frequently accompanied by neurological symptoms, such as myoclonus, expressive aphasia, hypertonia, and seizures, or autonomic symptoms, such as pyrexia and elevated blood pressure.

Based on the available information provided in the AERS cases and literature, FDA has concluded that the concomitant administration of a serotonergic psychiatric medication with methylene blue has the potential for a drug interaction causing serotonin syndrome. It appears this potential drug interaction can also occur following the discontinuation of serotonergic psychiatric medications with long half-lives. As a result, methylene blue should generally not be given to patients taking serotonergic drugs unless the benefit is deemed to outweigh the risk.

References
Bach KK, Lindsay FW, Berg LS, Howard RS. Prolonged postoperative disorientation after methylene blue infusion during parathyroidectomy. Anesth Analg. 2004;99:1573-4.
Kartha SS, Chacko CE, Bumpous JM, Fleming M, Lentsch EJ, Flynn MB. Toxic metabolic encephalopathy after parathyroidectomy with methylene blue localization. Otolaryngol Head Neck Surg. 2006;135:765-8.
Sweet G, Standiford SB. Methylene-blue-associated encephalopathy. J Am Coll Surg. 2007;204:454-8.

Source: http://www.fda.gov/Drugs/DrugSafety/ucm263190.htm

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Beerse, Belgium (March 9, 2011) — Janssen-Cilag International NV today announced that XEPLION® (paliperidone palmitate), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia.

 Schizophrenia is relatively common and the prevalence is similar around the world. The lifetime risk for schizophrenia is estimated to be one person in 100, and appears to be the same for men and women up to age 60 years.[1] Schizophrenia is a devastating mental illness for both the patients and their families and friends, as it seriously impairs a person’s ability to think clearly, relate to others and to function properly in society. While there is no cure, many people with the illness respond well to antipsychotic medicines, the mainstay of treatment for schizophrenia.

 However, further relapses can have a terrible effect on the lives of patients with schizophrenia and their families. Frequent relapses and hospitalisation can increase the person’s isolation and make it even more difficult for them to find and keep a job.[2],[3],[4],[5],[6] Prevention of future relapses is a crucial goal of therapy and patients who stay on continual treatment are more likely to achieve optimal outcomes.[7],[8]

 Patients with schizophrenia who are non-adherent to medication are up to five times more likely to relapse than those patients who are adherent and continue on medication, significantly increasing the likelihood of hospitalisation,[9] which in turn increases the overall cost of care.

 “Relapse can have a devastating effect on patients with schizophrenia and more needs to be done to actively improve adherence to medication if we are to break the cycle of decline,” said Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, Spain.* “Long-acting injectable antipsychotics such as XEPLION® can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients.”

The Clinical Data

 The efficacy of XEPLION® was established in four double-blind placebo controlled studies in patients with an acute exacerbation of schizophrenia and a longer-term double blind relapse prevention/maintenance study.[10],[11] ,[12],[13],[14] XEPLION® was superior to placebo in improving symptoms of schizophrenia as measured by the change in the positive and negative syndrome scale (PANSS) total scores from baseline to endpoint in the acute treatment trials and significantly delayed time to relapse vs. placebo in the longer-term maintenance study.[15]

 The most recent acute symptom control study was a multi-centre, randomised, placebo-controlled, double-blind, parallel-group study (n=636). [10] All patients received a dose of 150 mg eq. on Day 1 in the deltoid muscle. From Day 8 and monthly thereafter, patients were assigned to one of three fixed doses of XEPLION® (25, 100 and 150 mg eq) administered into either the deltoid or gluteal muscle for a period of 13 weeks. All three doses of XEPLION® were superior to placebo in improving the PANSS total score at endpoint (the primary measure of efficacy). The results support efficacy across the entire duration of treatment, with onset of efficacy and significant improvement in PANSS compared to placebo observed from day 8 in some patients. The results of the other studies also yielded significant results in favour of XEPLION®.[13]

 The efficacy of XEPLION® in maintaining symptomatic control and delaying relapse in schizophrenia was established in a longer-term, randomised, double-blind, placebo-controlled, flexible-dose study involving 849 patients with schizophrenia.[14] A total of 410 stabilised patients were randomised to either XEPLION® or to placebo until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase of the study. The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001) was seen in patients treated with XEPLION® compared to placebo. During the double-blind phase of the study, fewer patients treated with XEPLION® experienced a relapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]).[14] The final analyses confirmed the results of the interim analysis.

 “XEPLION® provides healthcare professionals with the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies,” says Dr Christophe Tessier**, Medical Affairs Director, Psychiatry, Janssen EMEA. “The approval of XEPLION® demonstrates Janssen’s ongoing commitment to providing novel therapies for schizophrenia. As a once monthly injection, XEPLION® can help healthcare professionals address the issue of non-adherence to medication thus ensuring symptom control and allowing patients to focus on shaping their lives.”

About XEPLION® (paliperidone palmitate)

XEPLION® is a once-monthly, long-acting, injectable, atypical antipsychotic. XEPLION® will be available in Europe in milligrams (mg) of paliperidone palmitate in dose strengths of 25***, 50, 75, 100 and 150 mg. After the first two initiation injections, XEPLION® can be administered in either the deltoid (arm) or gluteal (buttock) muscle.

 The approved indication is:

 XEPLION® is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION® may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Tolerability

 In the clinical development programme XEPLION® was generally well tolerated with no new safety signals identified in comparison to oral paliperidone ER with the exception of local injection site reactions.[10-14] The most frequently reported adverse effects during the clinical trials were insomnia (difficulty sleeping), headache, weight increase, injection site reactions, agitation, somnolence, akathisia (restlessness), nausea, constipation, dizziness, tremor, vomiting, upper respiratory tract infection (infection of the nose, throat, or chest), diarrhoea, and tachycardia (rapid heart rate).[15]

 XEPLION® was developed utilising Elan Drug Technologies’ proprietary NanoCrystal® Technology. Using this technology increases the rate of dissolution and enables the formulation of an aqueous suspension for once-monthly intramuscular administration.

About Schizophrenia

 Schizophrenia is a chronic, severe and disabling brain disorder that seriously impairs a person’s ability to think clearly, relate to others and to function productively in society. The consequences of the disorder include difficulties in thought processes leading to hallucinations, delusions, disordered thinking and unusual speech or behaviour.

About Janssen

 Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at http://www.janssen-emea.com

 (This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen-Cilag International NV’s and/or Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen-Cilag International NV nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

 Notes

 * Professor Fernando Cañas has at times been a paid consultant of Janssen.

 ** Dr Christophe Tessier is a full time employee of Janssen, EMEA.

 *** 25mg will not be available in all countries.

 References

 ———————————

 [1] Lehman A et al. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;161(2 Suppl):1-56

 [2] Thornicroft G, Brohan E, Rose D, et al for the INDIGO Study Group. Lancet.2009;373(9661):408-15.

 [3] Marwaha S, Johnson S, Bebbington P, et al. Br J Psychiatry. 2007;191:30-7.

 [4] Marwaha S, Johnson S. Soc Psychiatry Psychiatr Epidemiol. 2004;39(5):337-49.

 [5] Nithsdale V, Davies J, Croucher P. J Occup Rehabil. 2008;18(2 ):175-82.

 [6] Rosenheck R, Leslie D, Keefe R, et al; CATIE Study Investigators Group. Am J Psychiatry. 2006;163(3):411-417.

 [7] Masand PS, Roca M, Turner MS et al. Partial adherence to antipsychotic medication impacts course of illness in patients with schizophrenia: a review. Prim Care Companion J Clin Psychiatry. 2009;11(4):147-54.

 [8] Peuskens J, Olivares JM, Pecenak J et al. Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries. Curr Med Res Opin 2010;26:501-509

 [9] Kane JM. Treatment adherence and long-term outcomes. CNS Spectrums. 2007: 12 (10 Suppl 17), 21-26.

 [10] Pandina et al. A Randomised, Placebo Controlled Study to Assess the Efficacy and Safety of 3 Doses of paliperidone Palmitate in Adults With Acutely Exacerbated Schizophrenia. J Clin Psychopharmacol. 2010; 30: 235-244.

 [11] Nasrallah HA et al. A controlled evidence based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology. 2010; 35(10): 207-282.

 [12] Gopal S et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacology. 2010; 25(5): 24756

 [13] Kramer et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacology. 2009; 27: p113.

 [14] Hough D et al. Paliperidone palmitate maintenance treatment in delaying the time to relapse in patients with schizophrenia: A randomized, double-blind placebo-controlled study. Schizophrenia Research. 2010; 116 (23): 107-117.

 [15] Xeplion® SmPC 2011

Source: http://www.jnj.com/connect/news/all/european-commission-approves-xeplion-for-treatment-of-schizophrenia

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Generic name: aripiprazole

Read this Medication Guide before you start taking ABILIFY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ABILIFY (aripiprazole)?

(For other side effects, also see “What are the possible side effects of ABILIFY?”).

Serious side effects may happen when you take ABILIFY, including:

• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

• Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying

• attempts to commit suicide

• new or worse depression

• new or worse anxiety

• feeling very agitated or restless

• panic attacks

• trouble sleeping (insomnia)

• new or worse irritability

• acting aggressive, being angry, or violent

• acting on dangerous impulses

• an extreme increase in activity and talking (mania)

• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

What is ABILIFY?

ABILIFY is a prescription medicine used to treat:

• schizophrenia in people age 13 years and older.

• bipolar I disorder in people age 10 years and older, including:

• manic or mixed episodes that happen with bipolar I disorder.

• manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate.

• long-term treatment of bipolar I disorder.

• major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone.

• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old.

• agitation associated with schizophrenia or bipolar disorder.

The symptoms of schizophrenia include:

• losing touch with reality (psychosis)

• seeing things or hearing voices that are not there (hallucinations)

• believing things that are not true (delusions)

• being suspicious (paranoia)

• disorganized speech and thinking

• bizarre behavior

The symptoms of bipolar I disorder include:

• extreme mood swings that include feeling depressed and high or irritable mood

• talking too fast and too much

• impulsive behavior

• having more energy and restlessness than usual

• needing less sleep than usual

The symptoms of major depressive disorder (MDD) include:

• feeling of sadness and emptiness

• loss of interest in activities that you once enjoyed and loss of energy

• problems focusing and making decisions

• feeling of worthlessness or guilt

• changes in sleep or eating patterns

• thoughts of death or suicide

The symptoms of irritability associated with autistic disorder include:

• aggressive behavior towards others

• intentionally trying to harm oneself

• temper tantrums

• quickly changing moods

The symptoms of agitation associated with schizophrenia or bipolar disorder include:

• hostility or aggressive behavior

• agitation and inner tension

• self-exhausting behavior

What should I tell my healthcare provider before taking ABILIFY?

Before taking ABILIFY, tell your healthcare provider if you have or had:

• diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start ABILIFY and also during therapy.

• seizures (convulsions).

• low or high blood pressure.

• heart problems or stroke.

• pregnancy or plans to become pregnant. It is not known if ABILIFY will harm your unborn baby.

• breast-feeding or plans to breast-feed. It is not known if ABILIFY will pass into your breast milk. You and your healthcare provider should decide if you will take ABILIFY or breast-feed. You should not do both.

• low white blood cell count.

• phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine.

• any other medical conditions.

Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works.

Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ABILIFY?

• Take ABILIFY exactly as your healthcare provider tells you to take it.

Do not change the dose or stop taking ABILIFY yourself.

• ABILIFY can be taken with or without food.

• ABILIFY tablets should be swallowed whole.

• If you miss a dose of ABILIFY, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ABILIFY at the same time.

• If you have been prescribed ABILIFY DISCMELT, take it as follows:

• Do not open the blister until ready to take the DISCMELT tablet.

• To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.

• Do not push the tablet through the foil because this could damage the tablet.

• Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue.

• Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.

• Do not attempt to split the DISCMELT tablet.

• If you take too much ABILIFY, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking ABILIFY?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy.

• Do not drink alcohol while taking ABILIFY.

• Avoid getting over-heated or dehydrated.

• Do not over-exercise.

• In hot weather, stay inside in a cool place if possible.

• Stay out of the sun. Do not wear too much or heavy clothing.

• Drink plenty of water.

What are the possible side effects of ABILIFY?

Serious side effects have been reported with ABILIFY including: Also see “What is the most important information I should know about ABILIFY?” at the beginning of this Medication Guide.

• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.

• High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start ABILIFY and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking ABILIFY:

• feel very thirsty

• need to urinate more than usual

• feel very hungry

• feel weak or tired

• feel sick to your stomach

• feel confused, or your breath smells fruity.

• Difficulty swallowing: may lead to aspiration and choking.

• Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking ABILIFY. Tardive dyskinesia may also start after you stop taking ABILIFY.

• Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position.

• Low white blood cell count

• Seizures (convulsions)

Common side effects with ABILIFY in adults include:

• nausea • inner sense of restlessness/need to move

• vomiting (akathisia)

• constipation • anxiety

• headache • insomnia

• dizziness • restlessness

Common side effects with ABILIFY in children include:

• feeling sleepy • insomnia

• headache • nausea

• vomiting • stuffy nose

• fatigue • weight gain

• increased appetite • uncontrolled movement such as restlessness, tremor, muscle stiffness

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ABILIFY?

• Store ABILIFY at room temperature, between 59°F to 86°F (15°C to 30°C).

• Opened bottles of ABILIFY Oral Solution can be used for up to

6 months after opening, but not beyond the expiration date on the bottle.

Keep ABILIFY and all medicines out of the reach of children.

General information about ABILIFY

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals. For more information about ABILIFY visit www.abilify.com.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Source: http://packageinserts.bms.com/medguide/medguide_abilify.pdf

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Psychotherapy, or “talk therapy,” is a way to treat people with a mental disorder by helping them understand their illness. It teaches people strategies and gives them tools to deal with stress and unhealthy thoughts and behaviors. Psychotherapy helps patients manage their symptoms better and function at their best in everyday life.

Sometimes psychotherapy alone may be the best treatment for a person, depending on the illness and its severity. Other times, psychotherapy is combined with medications. Therapists work with an individual or families to devise an appropriate treatment plan.

What are the different types of psychotherapy?

Many kinds of psychotherapy exist. There is no “one-size-fits-all” approach. In addition, some therapies have been scientifically tested more than others. Some people may have a treatment plan that includes only one type of psychotherapy. Others receive treatment that includes elements of several different types. The kind of psychotherapy a person receives depends on his or her needs.

This section explains several of the most commonly used psychotherapies. However, it does not cover every detail about psychotherapy. Patients should talk to their doctor or a psychotherapist about planning treatment that meets their needs.

Cognitive Behavioral Therapy

Cognitive behavioral therapy (CBT) is a blend of two therapies: cognitive therapy (CT) and behavioral therapy. CT was developed by psychotherapist Aaron Beck, M.D., in the 1960′s. CT focuses on a person’s thoughts and beliefs, and how they influence a person’s mood and actions, and aims to change a person’s thinking to be more adaptive and healthy. Behavioral therapy focuses on a person’s actions and aims to change unhealthy behavior patterns.

CBT helps a person focus on his or her current problems and how to solve them. Both patient and therapist need to be actively involved in this process. The therapist helps the patient learn how to identify distorted or unhelpful thinking patterns, recognize and change inaccurate beliefs, relate to others in more positive ways, and change behaviors accordingly.

CBT can be applied and adapted to treat many specific mental disorders.
CBT for depression

Many studies have shown that CBT is a particularly effective treatment for depression, especially minor or moderate depression. Some people with depression may be successfully treated with CBT only. Others may need both CBT and medication. CBT helps people with depression restructure negative thought patterns. Doing so helps people interpret their environment and interactions with others in a positive and realistic way. It may also help a person recognize things that may be contributing to the depression and help him or her change behaviors that may be making the depression worse.

CBT for anxiety disorders

CBT for anxiety disorders aims to help a person develop a more adaptive response to a fear. A CBT therapist may use “exposure” therapy to treat certain anxiety disorders, such as a specific phobia, post traumatic stress disorder, or obsessive compulsive disorder. Exposure therapy has been found to be effective in treating anxiety-related disorders.  It works by helping a person confront a specific fear or memory while in a safe and supportive environment. The main goals of exposure therapy are to help the patient learn that anxiety can lessen over time and give him or her the tools to cope with fear or traumatic memories.

A recent study sponsored by the Centers for Disease Control and Prevention concluded that CBT is effective in treating trauma-related disorders in children and teens.

CBT for bipolar disorder

People with bipolar disorder usually need to take medication, such as a mood stabilizer. But CBT is often used as an added treatment. The medication can help stabilize a person’s mood so that he or she is receptive to psychotherapy and can get the most out of it. CBT can help a person cope with bipolar symptoms and learn to recognize when a mood shift is about to occur. CBT also helps a person with bipolar disorder stick with a treatment plan to reduce the chances of relapse (e.g., when symptoms return).
CBT for eating disorders

Eating disorders can be very difficult to treat. However, some small studies have found that CBT can help reduce the risk of relapse in adults with anorexia who have restored their weight.  CBT may also reduce some symptoms of bulimia, and it may also help some people reduce binge-eating behavior.

CBT for schizophrenia

Treating schizophrenia with CBT is challenging. The disorder usually requires medication first. But research has shown that CBT, as an add-on to medication, can help a patient cope with schizophrenia.5 CBT helps patients learn more adaptive and realistic interpretations of events. Patients are also taught various coping techniques for dealing with “voices” or other hallucinations. They learn how to identify what triggers episodes of the illness, which can prevent or reduce the chances of relapse.

CBT for schizophrenia also stresses skill-oriented therapies. Patients learn skills to cope with life’s challenges. The therapist teaches social, daily functioning, and problem-solving skills. This can help patients with schizophrenia minimize the types of stress that can lead to outbursts and hospitalizations.

Source: http://www.nimh.nih.gov/health/topics/psychotherapies/index.shtml

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Attention Deficit Hyperactivity Disorder (ADHD) is a condition that becomes apparent in some children in the preschool and early school years. It is hard for these children to control their behavior and/or pay attention. It is estimated that between 3 and 5 percent of children have ADHD, or approximately 2 million children in the United States. This means that in a classroom of 25 to 30 children, it is likely that at least one will have ADHD. (Source: NIMH, www.nimh.nih.gov, accessed February 11, 2009)

Autism Spectrum Disorder also known as Pervasive Developmental Disorders (PDDs), cause severe and pervasive impairment in thinking, feeling, language, and the ability to relate to others. A recent study of a U.S. metropolitan area estimated that 3.4 of every 1,000 children 3-10 years old had autism. (Source: NIMH, www.nimh.nih.gov, accessed February 11, 2009)

Bipolar Disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in a person’s mood, energy, and ability to function. About 5.7 million American adults or about 2.6 percent of the population age 18 and older in any given year, have bipolar disorder. Both children and adolescents can develop bipolar disorder. It is more likely to affect the children of parents who have the illness. (Source: NIMH, www.nimh.nih.gov, accessed February 11, 2009)

Conduct disorder, also known as disruptive behavior disorder, is a disorder that involves chronic behavior problems during childhood and adolescence including stealing, fighting, or bullying others. Conduct disorder affects 1 to 4 percent of 9- to 17-year-olds, depending on exactly how the disorder is defined, and seems to be more common in boys than in girls. (Source: SAMHSA, www.mentalhealth.samhsa.gov, accessed March 18, 2009)

Depression is a treatable illness. Major depression is more than a sad mood, depression affects a young person’s ability to think, feel, and behave in a normal manner. Major depression can lead to school failure, alcohol and drug use, and even suicide. At any point in time, 1 in every 10 children and adolescents are affected by serious emotional disturbances. (Source: SAMHSA, www.mentalhealth.samhsa.gov, accessed March 18, 2009)

Eating Disorders are severe disturbances in eating behavior. There are two main types of eating disorders: anorexia nervosa and bulimia nervosa. Eating disorders frequently appear in adolescence. Although eating disorders are more common in females, approximately 5 to 15 percent of individuals diagnosed with anorexia or bulimia are male. Individuals with anorexia are up to ten times more likely to die because of their illness. (Source: NIMH, www.nimh.nih.gov, accessed March 18, 2009)

Oppositional Defiant Disorder (ODD) is a persistent pattern of disobedient, hostile, and defiant behavior towards various authority figures. Some studies have shown that 1 to 6 percent of the school-age population is affected. The disorder is more common in boys prior to puberty but after puberty, both genders are equal. (Source: SAMHSA, www.mentalhealth.samhsa.gov, accessed March 18, 2009)

Post-Traumatic Stress Disorder (PTSD) is a condition that affects individuals who have experienced a disturbing or frightening event. PTSD generally starts within three months of the event, however for some individuals it doesn’t appear until much later. In any given year, 5.2 million Americans (including children and adolescents) suffer from PTSD. (Source: SAMHSA, www. mentalhealth.samhsa.gov, accessed March 18, 2009)

Risk-Taking Behavior is any action that increases the likelihood of injury or death. 72% of all deaths among 10-24 year-olds result from four causes: motor-vehicle crashes, other unintentional injuries, homicide, and suicide. The 2007 National Youth Risk Behavior Survey indicated that over a thirty day span, 29.1% of high school students surveyed had ridden in a car with a driver who had been drinking alcohol and 18% had carried a weapon. Over a 12 month span, 6.9% of high school students had attempted suicide, 75% had drunk alcohol, and 47.8% had sexual intercourse. (Source: Eaton, et. al., Youth Risk Behavior Surveillance–United States, 2007, CDC, www.cdc.gov, accessed March 18, 2009.)

Schizophrenia is a chronic and disabling brain disorder. It affects about 1% of Americans. Psychotic symptoms usually appear in males during their late teens and early 20s and in females in their mid-20s to early 30s. Symptoms seldom appear after the age of 45 and rarely before puberty. (Source: NIMH, www.nimh.nih.gov, accessed March 18, 2009)

Suicide is the third leading cause of death for 15-to-24-year-olds, among this age group, suicide accounts for 12.3% of all deaths. In 2007, 6.9% of high school student surveyed through the Youth Risk Behavior Survey indicated they had attempted suicide in the last 12 months, and 14.5% had seriously considered attempting suicide. The warning signs and risk factors associated with suicide include: depression, previous suicide attempts, recent losses, frequent thoughts about death, and the use of drugs or alcohol. (Source: CDC, www.cdc.gov, accessed March 18, 2009)

Child and Adolescent Drug Abuse Statistics

An estimated 19.9 million Americans aged 12 or older were current users of an illicit drug in 2007. This estimate represents 8.0 percent of the population.

An estimated 70.9 million Americans reported being current users of a tobacco product in 2007, a prevalence rate of 28.6% of the population 12 years and older.

Marijuana is the most widely used illicit substance in this country. In 2007, 14.4 million people were current users of marijuana.

Vicodin is one of the drugs most commonly abused by adolescents. In 2008, 15.4% of 12th graders reporting using a prescription drug for non-medical purposes in the last year.

(Source: NIDA, www.nida.nih.gov, accessed March 18, 2009. Data provided from the NIDA funded Monitoring the Future: National Survey Results on Drug Use and the SAMHSA funded 2007 National Survey on Drug Use and Health.)[1]

Source:

1-http://www.aacap.org/cs/root/resources_for_families/child_and_adolescent_mental_illness_statistics

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There are quite significant differences between psychology, psychiatry and psychotherapy roles and they tend to deal with different types of problems, although there is considerable overlap in their work, below is a brief description of each of the careers and you can explore psychology and psychotherapy individually by clicking on the links in “Related information…”

What is psychology?

Psychology is the study of people: how they think, how they act, react and interact. Psychology is concerned with all aspects of behaviour and the thoughts, feelings and motivation underlying such behaviour.

Psychology is a discipline that is firstly concerned with the normal functioning of the mind and has explored areas such as learning, remembering and the normal psychological development of children. Psychology is one of the fastest growing university subjects and is becoming more and more available in schools and colleges.

Psychologists deal in the way the mind works and motivation, and can specialise in various areas such as; mental health work and educational and occupational psychology.

It is useful to remember that psychologists are not usually medically qualified and only a small proportion of people studying psychology degrees will go on to work with patients.

What is psychiatry?

Psychiatry is the study of mental disorders and their diagnosis, management and prevention. Psychiatrists are medical doctors who have qualified in psychiatry. They often combine a broad general caseload alongside an area of special expertise and research.

What is psychotherapy?

Psychotherapy is conducted in several different ways for example individual, group, couple and family psychotherapy. They are all ways of helping people to overcome stress, emotional problems, relationship problems or troublesome habits.

There are many different approaches in psychotherapy, these are “talking therapies” which include;

• cognitive behavioural therapies
• psychoanalytic therapies
• psychodynamic therapies
• systemic and family psychotherapy
• arts therapies
• play therapies
• humanistic and integrative psychotherapies
• hypno-psychotherapy
• experiential constructivist therapies

A psychotherapist may be a psychiatrist, psychologist or other mental health professional who has had further specialist training in psychotherapy. Increasingly there are a number of psychotherapists who do not have backgrounds in the above fields but who have undertaken in depth training in this area.

Consultant psychiatrists in psychotherapy are medical doctors who have qualified in psychiatry and then undertaken a three or four-year specialist training in psychotherapy. Their role is in the psychotherapeutic treatment of patients with psychiatric illnesses.[1]

The difference between psychologists and psychiatrists

Psychologists and psychiatrists both work in the area of mental health, and often work together. However, there are some significant differences between the two professions in the following areas.

Education and qualifications

Psychologists study human behaviour in their undergraduate and postgraduate degrees before undertaking supervised experience and gaining registration. They do not have a medical degree; however, many have postgraduate qualifications to specialise in various aspects of psychology, including mental illness.

Psychiatrists have a medical degree, which involves six years of studying general medicine, followed by further study to specialise in the diagnosis and treatment of mental illness and emotional problems.

Services provided

Psychologists assist people with everyday problems such as stress and relationship difficulties, and some specialise in treating people with a mental illness. They help people to develop the skills needed to function better and to prevent ongoing problems.

Psychiatrists treat the effects of emotional disturbances on the body and the effects of physical conditions on the mind.

Prescribing medication

Psychologists cannot prescribe medication. Their treatments are based on changing behaviour and emotional responses without medication. There is a considerable amount of evidence showing psychological treatments are effective.

Psychiatrists can prescribe medication. Some combine medication with other forms of therapy.[2]

Source:

1- http://www.nhscareers.nhs.uk/details/Default.aspx?Id=290

2- http://www.psychology.org.au/community/about/

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The word “schizophrenia” has a scientific sound that seems to give it inherent credibility and a charisma that seems to dazzle people. In his book Molecules of the Mind – The Brave New Science of Molecular Psychology, University of Maryland journalism professor Jon Franklin calls schizophrenia and depression “the two classic forms of mental illness” (Dell Publishing Co., 1987, p. 119). According to the cover article in the July 6, 1992 Time magazine, schizophrenia is the “most devilish of mental illnesses” (p. 53). This Time magazine article says “fully a quarter of the nation’s hospital beds are occupied by schizophrenia patients” (p. 55). Books and articles like these and the facts to which they refer (such as a quarter of hospital beds being occupied by so-called schizophrenics) delude most people into believing there really is a disease called schizophrenia. Schizophrenia is one of the great myths of our time.
In his book Schizophrenia – The Sacred Symbol of Psychiatry, psychiatry professor Thomas S. Szasz, M.D., says “There is, in short, no such thing as schizophrenia” (Syracuse University Press, 1988, p. 191). In the Epilogue of their book Schizophrenia – Medical Diagnosis or Moral Verdict?, Theodore R. Sarbin, Ph.D., a psychology professor at the University of California at Santa Cruz who spent three years working in mental hospitals, and James C. Mancuso, Ph.D., a psychology professor at the State University of New York at Albany, say: “We have come to the end of our journey. Among other things, we have tried to establish that the schizophrenia model of unwanted conduct lacks credibility. The analysis directs us ineluctably to the conclusion that schizophrenia is a myth” (Pergamon Press, 1980, p. 221). In his book Against Therapy, published in 1988, Jeffrey Masson, Ph.D., a psychoanalyst, says “There is a heightened awareness of the dangers inherent in labeling somebody with a disease category like schizophrenia, and many people are beginning to realize that there is no such entity” (Atheneum, p. 2). Rather than being a bona-fide disease, so-called schizophrenia is a nonspecific category which includes almost everything a human being can do, think, or feel that is greatly disliked by other people or by the so-called schizophrenics themselves. There are few so-called mental illnesses that have not at one time or another been called schizophrenia. Because schizophrenia is a term that covers just about everything a person can think or do which people greatly dislike, it is hard to define objectively. Typically, definitions of schizophrenia are vague or inconsistent with each other. For example, when I asked a physician who was the Assistant Superintendent of a state mental hospital to define the term schizophrenia for me, he with all seriousness replied “split personality – that’s the most popular definition.” In contrast, a pamphlet published by the National Alliance for the Mentally Ill titled “What Is Schizophrenia?” says “Schizophrenia is not a split personality”. In her book Schiz-o-phre-nia: Straight Talk for Family and Friends, published in 1985, Maryellen Walsh says “Schizophrenia is one of the most misunderstood diseases on the planet. Most people think that it means having a split personality. Most people are wrong. Schizophrenia is not a splitting of the personality into multiple parts” (Warner Books, p. 41). The American Psychiatric Association’s (APA’s) Diagnostic and Statistical Manual of Mental Disorders (Second Edition), also known as DSM-II, published in 1968, defined schizophrenia as “characteristic disturbances of thinking, mood, or behavior” (p. 33). A difficulty with such a definition is it is so broad just about anything people dislike or consider abnormal, i.e., any so-called mental illness, can fit within it. In the Foreword to DSM-II, Ernest M. Gruenberg, M.D., D.P.H., Chairman of the American Psychiatric Association’s Committee on Nomenclature, said: “Consider, for example, the mental disorder labeled in the Manual as ‘schizophrenia,’ … Even if it had tried, the Committee could not establish agreement about what this disorder is” (p. ix). The third edition of the APA’s Diagnostic and Statistical Manual of Mental Disorders, published in 1980, commonly called DSM-III, was also quite candid about the vagueness of the term. It said: “The limits of the concept of Schizophrenia are unclear” (p. 181). The revision published in 1987, DSM-III-R, contains a similar statement: “It should be noted that no single feature is invariably present or seen only in Schizophrenia” (p. 188). DSM-III-R also says this about a related diagnosis, Schizoaffective Disorder: “The term Schizoaffective Disorder has been used in many different ways since it was first introduced as a subtype of Schizophrenia, and represents one of the most confusing and controversial concepts in psychiatric nosology” (p. 208).
Particularly noteworthy in today’s prevailing intellectual climate in which mental illness is considered to have biological or chemical causes is what DSM-III-R, says about such physical causes of this catch-all concept of schizophrenia: It says a diagnosis of schizophrenia “is made only when it cannot be established that an organic factor initiated and maintained the disturbance” (p. 187). Underscoring this definition of “schizophrenia” as non-biological is the 1987 edition of The Merck Manual of Diagnosis and Therapy, which says a (so-called) diagnosis of schizophrenia is made only when the behavior in question is “not due to organic mental disorder” (p. 1532).
Contrast this with a statement by psychiatrist E. Fuller Torrey, M.D., in his book Surviving Schizophrenia: A Family Manual, published in 1988. He says “Schizophrenia is a brain disease, now definitely known to be such” (Harper & Row, p. 5). Of course, if schizophrenia is a brain disease, then it is organic. However, the official definition of schizophrenia maintained and published by the American Psychiatric Association in its Diagnostic and Statistical Manual of Mental Disorders for many years specifically excluded organically caused conditions from the definition of schizophrenia. Not until the publication of DSM-IV in 1994 was the exclusion for biologically caused conditions removed from the definition of schizophrenia. In Surviving Schizophrenia, Dr. Torrey acknowledges “the prevailing psychoanalytic and family interaction theories of schizophrenia which were prevalent in American psychiatry” (p. 149) which would seem to account for this.
In the November 10, 1988 issue of Nature, genetic researcher Eric S. Lander of Harvard University and M.I.T. summarized the situation this way: “The late US Supreme Court Justice Potter Stewart declared in a celebrated obscenity case that, although he could not rigorously define pornography, ‘I know it when I see it’. Psychiatrists are in much the same position concerning the diagnosis of schizophrenia. Some 80 years after the term was coined to describe a devastating condition involving a mental split among the functions of thought, emotion and behaviour, there remains no universally accepted definition of schizophrenia” (p. 105).
According to Dr. Torrey in his book Surviving Schizophrenia, so-called schizophrenia includes several widely divergent personality types. Included among them are paranoid schizophrenics, who have “delusions and/or hallucinations” that are either “persecutory” or “grandiose”; hebephrenic schizophrenics, in whom “well-developed delusions are usually absent”; catatonic schizophrenics who tend to be characterized by “posturing, rigidity, stupor, and often mutism” or, in other words, sitting around in a motionless, nonreactive state (in contrast to paranoid schizophrenics who tend to be suspicious and jumpy); and simple schizophrenics, who exhibit a “loss of interest and initiative” like the catatonic schizophrenics (though not as severe) and unlike the paranoid schizophrenics have an “absence of delusions or hallucinations” (p. 77). The 1968 edition of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, DSM-II, indicates a person who is very happy (experiences “pronounced elation”) may be defined as schizophrenic for this reason (“Schizophrenia, schizo-affective type, excited”) or very unhappy (“Schizophrenia, schizo-affective type, depressed”)(p. 35), and the 1987 edition, DSM-III-R, indicates a person can be “diagnosed” as schizophrenic because he displays neither happiness nor sadness (“no signs of affective expression”)(p. 189), which Dr. Torrey in his book calls simple schizophrenia (“blunting of emotions”)(p. 77). According to psychiatry professor Jonas Robitscher, J.D., M.D., in his book The Powers of Psychiatry, people who cycle back and forth between happiness and sadness, the so-called manic-depressives or suffers of “bipolar mood disorder”, may also be called schizophrenic: “Many cases that are diagnosed as schizophrenia in the United States would be diagnosed as manic-depressive illness in England or Western Europe” (Houghton Mifflin, 1980, p. 165.) So the supposed “symptoms” or defining characteristics of “schizophrenia” are broad indeed, defining people as having some kind of schizophrenia because they have delusions or do not, hallucinate or do not, are jumpy or catatonic, are happy, sad, or neither happy nor sad, or cycling back and forth between happiness and sadness. Since no physical causes of “schizophrenia” have been found, as we’ll soon see, this “disease” can be defined only in terms of its “symptoms”, which as you can see are what might be called ubiquitous. As attorney Bruce Ennis says in his book Prisoners of Psychiatry: “schizophrenia is such an all-inclusive term and covers such a large range of behavior that there are few people who could not, at one time or another, be considered schizophrenic” (Harcourt Brace Jovanovich, Inc., 1972, p. 22). People who are obsessed with certain thoughts or who feel compelled to perform certain behaviors, such as washing their hands repeatedly, are usually considered to be suffering from a separate psychiatric disease called “obsessive-compulsive disorder”. However, people with obsessive thoughts or compulsive behaviors have also been called schizophrenic (e.g., by Dr. Torrey in his book Surviving Schizophrenia, pp. 115-116).
In Surviving Schizophrenia, Dr. Torrey quite candidly concedes the impossibility of defining what “schizophrenia” is. He says: “The definitions of most diseases of mankind has been accomplished. … In almost all diseases there is something which can be seen or measured, and this can be used to define the disease and separate it from nondisease states. Not so with schizophrenia! To date we have no single thing which can be measured and from which we can then say: Yes, that is schizophrenia. Because of this, the definition of the disease is a source of great confusion and debate” (p. 73). What puzzles me is how to reconcile this statement of Dr. Torrey’s with another he makes in the same book, which I quoted above and which appears more fully as follows: “Schizophrenia is a brain disease, now definitely known to be such. It is a real scientific and biological entity, as clearly as diabetes, multiple sclerosis, and cancer are scientific and biological entities” (p. 5). How can it be known schizophrenia is a brain disease when we do not know what schizophrenia is?
The truth is that the label schizophrenia, like the labels pornography or mental illness, indicates disapproval of that to which the label is applied and nothing more. Like “mental illness” or pornography, “schizophrenia” does not exist in the sense that cancer and heart disease exist but exists only in the sense that good and bad exist. As with all other so-called mental illnesses, a diagnosis of “schizophrenia” is a reflection of the speaker’s or “diagnostician’s” values or ideas about how a person “should” be, often coupled with the false (or at least unproven) assumption that the disapproved thinking, emotions, or behavior results from a biological abnormality. Considering the many ways it has been used, it’s clear “schizophrenia” has no particular meaning other than “I dislike it.” Because of this, I lose some of my respect for mental health professionals when I hear them use the word schizophrenia in a way that indicates they think it is a real disease. I do this for the same reason I would lose respect for someone’s perceptiveness or intellectual integrity after hearing him or her admire the emperor’s new clothes. While the layman definition of schizophrenia, internally inconsistent, may make some sense, using the term “schizophrenia” in a way that indicates the speaker thinks it is a real disease is tantamount to admitting he doesn’t know what he is talking about.
Many mental health “professionals” and other “scientific” researchers do however persist in believing “schizophrenia” is a real disease. They are like the crowds of people observing the emperor’s new clothes, unable or unwilling to see the truth because so many others before them have said it is real. A glance through the articles listed under “Schizophrenia” in Index Medicus, an index of medical periodicals, reveals how widespread the schizophrenia myth has become. And because these “scientists” believe “schizophrenia” is a real disease, they try to find physical causes for it. As psychiatrist William Glasser, M.D., says in his book Positive Addiction, published in 1976: “Schizophrenia sounds so much like a disease that prominent scientists delude themselves into searching for its cure” (Harper & Row, p. 18). This is a silly endeavor, because these supposedly prominent scientists can’t define “schizophrenia” and accordingly don’t know what they are looking for.
According to three Stanford University psychiatry professors, “two hypotheses have dominated the search for a biological substrate of schizophrenia.” They say these two theories are the transmethylation hypothesis of schizophrenia and the dopamine hypothesis of schizophrenia. (Jack D. Barchas, M.D., et al., “Biogenic Amine Hypothesis of Schizophrenia”, appearing in Psychopharmacology: From Theory to Practice, Oxford University Press, 1977, p. 100.) The transmethylation hypothesis was based on the idea that “schizophrenia” might be caused by “aberrant formation of methylated amines” similar to the hallucinogenic pleasure drug mescaline in the metabolism of so-called schizophrenics. After reviewing various attempts to verify this theory, they conclude: “More than two decades after the introduction of the transmethylation hypothesis, no conclusions can be drawn about its relevance to or involvement in schizophrenia” (p. 107).
Columbia University psychiatry professor Jerrold S. Maxmen, M.D., succinctly describes the second major biological theory of so-called schizophrenia, the dopamine hypothesis, in his book The New Psychiatry, published in 1985: “…many psychiatrists believe that schizophrenia involves excessive activity in the dopamine-receptor system…the schizophrenic’s symptoms result partially from receptors being overwhelmed by dopamine” (Mentor, pp. 142 & 154). But in the article by three Stanford University psychiatry professors I referred to above they say “direct confirmation that dopamine is involved in schizophrenia continues to elude investigators” (p. 112). In 1987 in his book Molecules of the Mind Professor Jon Franklin says “The dopamine hypothesis, in short, was wrong” (p. 114).
In that same book, Professor Franklin aptly describes efforts to find other biological causes of so-called schizophrenia: “As always, schizophrenia was the index disease. During the 1940s and 1950s, hundreds of scientists occupied themselves at one time and another with testing samples of schizophrenics’ bodily reactions and fluids. They tested skin conductivity, cultured skin cells, analyzed blood, saliva, and sweat, and stared reflectively into test tubes of schizophrenic urine. The result of all this was a continuing series of announcements that this or that difference had been found. One early researcher, for instance, claimed to have isolated a substance from the urine of schizophrenics that made spiders weave cockeyed webs. Another group thought that the blood of schizophrenics contained a faulty metabolite of adrenaline that caused hallucinations. Still another proposed that the disease was caused by a vitamin deficiency. Such developments made great newspaper stories, which generally hinted, or predicted outright, that the enigma of schizophrenia had finally been solved. Unfortunately, in light of close scrutiny none of the discoveries held water” (p. 172).
Other efforts to prove a biological basis for so-called schizophrenia have involved brain-scans of pairs of identical twins when only one is a supposed schizophrenic. They do indeed show the so-called schizophrenic has brain damage his identical twin lacks. The flaw in these studies is the so-called schizophrenic has inevitably been given brain-damaging drugs called neuroleptics as a so-called treatment for his so-called schizophrenia. It is these brain-damaging drugs, not so-called schizophrenia, that have caused the brain damage. Anyone “treated” with these drugs will have such brain damage. Damaging the brains of people eccentric, obnoxious, imaginative, or mentally disabled enough to be called schizophrenic with drugs (erroneously) believed to have antischizophrenic properties is one of the saddest and most indefensible consequences of today’s widespread belief in the myth of schizophrenia.
In The New Harvard Guide to Psychiatry, published in 1988, Seymour S. Kety, M.D., Professor Emeritus of Neuroscience in Psychiatry, and Steven Matthysse, Ph.D., Associate Professor of Psychobiology, both of Harvard Medical School, say “an impartial reading of the recent literature does not provide the hoped-for clarification of the catecholamine hypotheses, nor does compelling evidence emerge for other biological differences that may characterize the brains of patients with mental disease” (Harvard University Press, p. 148).
Belief in biological causes of so-called mental illness, including schizophrenia, comes not from science but from wishful thinking or from desire to avoid coming to terms with the experiential/environmental causes of people’s misbehavior or distress. The repeated failure of efforts to find biological causes of so-called schizophrenia suggests “schizophrenia” belongs only in the category of socially/culturally unacceptable thinking or behavior rather than in the category of biology or “disease” where many people place it.

by Lawrence Stevens, J.D.

Source: http://www.antipsychiatry.org/schizoph.htm

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Almost all children have behavior issues from time to time. But, for children with ADHD, behavior problems are persistent and occur over a long period of time. For a child with ADHD, their symptoms can create challenges all day, every day — at home, at school and at play. That can make both child and parent feel frustrated and alone.

ADHD is a real and treatable medical condition that affects 5 million children in the United States. ADHD symptoms fall into 3 basic subtypes, which include inattentive, hyperactive/impulsive behavior, and a combination of both. These symptoms are persistent (in other words, they must be present for at least 6 months) and occur more frequently in children with ADHD than other children their age. For ADHD to be diagnosed, some symptoms must have been present and affecting behavior before age 6.

Among other symptoms, a child with ADHD may have trouble sitting still, finishing tasks, or following directions. ADHD can affect your child at school, at home, and at play.

Over the years, ADHD has been called ADD (Attention Deficit Disorder). While some still refer to the condition as ADD, the term is no longer in widespread use. ADHD is the updated clinical term as it most accurately describes all aspects of the condition.

In the United States, approximately 9% of the school-age population is diagnosed with ADHD. It’s the most commonly diagnosed behavioral condition in children today. Twice as many boys are diagnosed with ADHD as girls.

ADHD is not a discipline problem or a reflection of a child’s intelligence. Nor is it a result of poor parenting. ADHD is thought to be a biological condition that affects certain types of brain functioning. While the exact cause of the condition is still unknown, scientists have focused their research on chemical messengers, or neurotransmitters, in the brain. These messengers are believed to play a role in behaviors like attention and movement.

Much like height or eye color, ADHD can be inherited. Studies suggest that 76% of ADHD is linked to family genetics. So the condition is more common among people who have a close relative with ADHD. Adults with ADHD have a 50% chance of passing it on to their children.

While there’s no cure for ADHD, the symptoms of the condition can be effectively managed with treatments like CONCERTA®. CONCERTA® is a once-a-day prescription medication that can help your child focus at school and at home. It can even improve their social interactions.

If you think your child has ADHD, take the ADHD symptom screener, then schedule an evaluation with a healthcare professional. If your child is diagnosed with ADHD, ask about managing the everyday challenges of ADHD with CONCERTA®.

Signs & Symptoms of ADHD
A child can face challenging moments every day. Maybe it’s dealing with a new lesson at school, handling chores at home, or trying out for the team. But, if your child has ADHD, these moments can feel even more challenging. And that can be a lonely experience for your child – and for you, too.

ADHD is a condition that causes a child to display a persistent pattern of inattention and/or hyperactive/impulsive behavior that is more frequent and more severe than other children their age. ADHD symptoms can affect children all day and every day—at school, at home, and with other children.

Your child may have a hard time with focusing, sitting still, and completing tasks they start. The symptoms of ADHD can cause issues with social interactions, too. It may be hard for a child with ADHD to control their impulses, even when they know they are expected to behave.

Common signs and symptoms of ADHD in children:
Easily distracted
Trouble following directions
Poorly organized homework
Often makes careless mistakes
Forgetful
Frequently interrupts others
Trouble waiting turn in games or activities
Cannot stay seated, often fidgets or squirms

Not every child with ADHD has every symptom, or experiences the symptoms of ADHD to the same degree. ADHD symptoms are persistent, and must be present for at least 6 months.

If you think your child may have symptoms of ADHD, create a customized Doctor Discussion Guide then schedule an evaluation with a healthcare professional. If diagnosed with ADHD, ask about managing everyday challenges with CONCERTA®.

CONCERTA® can help your child successfully manage the symptoms of ADHD. A once-daily dose can help your child focus at school and at home. CONCERTA® can also improve their social interactions.

ADHD Treatment Options
When properly diagnosed and treated, ADHD can be effectively managed. A comprehensive approach to treating ADHD can be an effective way to treat the condition. This includes prescription medicine and counseling or behavioral therapy.

Once diagnosed, your child’s healthcare professional may prescribe a medication for ADHD. There is no cure for ADHD, and no one treatment is right for everyone. So, considering your child’s medical history, his or her healthcare professional may recommend a treatment plan that weighs the benefits and risks of each ADHD medication.

To date, the most commonly prescribed ADHD medications are from a class of drugs called stimulants, though nonstimulants may also be an effective treatment option. Stimulants are proven to reduce ADHD symptoms like inattention, impulsivity, and hyperactivity.

Stimulants are believed to enhance the availability of the brain’s chemical messengers dopamine and norepinephrine. These messengers are believed to play a role in behaviors like attention and movement.

Methylphenidate, the stimulant medicine in CONCERTA®, has been used for over 50 years. Today, CONCERTA® is the #1 ADHD medication prescribed for children and adolescents with ADHD.

ADHD medications are available in short- and long-acting formulations. The short-acting forms can last up to 4 hours. Long-acting forms, like CONCERTA®, are time-released. CONCERTA® starts working at 1 hour and lasts through 12.5 hours.* So it offers ADHD symptom control throughout the day, including those all-important homework hours between 4 and 6 pm.

Choosing a Healthcare Professional

Does your child show signs of inattentive, hyperactive, and/or impulsive behavior? Do you suspect he or she may have ADHD? If yes, it’s important to schedule an appointment with his or her healthcare professional.

Your child’s healthcare professional may make a diagnosis. Or may refer you to a specialist who’s more experienced in diagnosing ADHD, like a child psychiatrist or neurologist. Psychologists and nurse practitioners can diagnose ADHD. And some are licensed to write prescriptions for medication.

Since no single laboratory test for ADHD exists, ADHD can be difficult to diagnose. Your child’s healthcare professional will likely guide you through a list of questions that rate ADHD symptoms and rule out other potential conditions. You may be asked about your child’s experiences at school, at home, and in social settings.

A comprehensive approach to treating ADHD includes both medication and behavioral therapy. This is thought to be an effective way to treat children with ADHD. Psychologists, social workers, counselors, and family therapists can provide behavioral therapy for children with ADHD.

Be prepared to talk with your child’s healthcare professional by creating a customized Doctor Discussion Guide. If diagnosed with ADHD, ask how treatment with CONCERTA® may help your child manage ADHD symptoms.

CONCERTA® Basics

CONCERTA® is a prescription product approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.

One dose of CONCERTA® provides long-lasting ADHD symptom control. CONCERTA® starts working at 1 hour, and lasts through 12.5 hours.* So one morning dose covers your child’s busy day — including the all-important homework hours between the hours of 4 and 6 pm.

Methylphenidate, the medication in CONCERTA® has been prescribed for over 50 years. CONCERTA® is recommended among first-line therapies by the American Academy of Pediatrics, as part of a total treatment program. This includes both medication and behavioral therapy.

CONCERTA® is proven to help manage the symptoms of inattention, hyperactivity, and impulsivity. With these symptoms under control, your child can focus better and pay closer attention to the things he or she is doing throughout the day. All of this may help your child manage ADHD symptoms at school, at home, and at play.

In a study, teachers reported that children taking CONCERTA® showed improvements in ADHD symptoms as measured in areas such as focusing better, paying better attention, and completing projects they started.** In a laboratory school study, improved attention in children was demonstrated by completing more math problems accurately throughout the day, compared with placebo. CONCERTA® is also proven to help improve social interactions.

CONCERTA® is approved for doses up to 54 mg per day in children and 72 mg per day in adolescents. Children are typically started on a daily dose of 18 mg of CONCERTA®. But, like many ADHD medications, your child’s dosage may need to be adjusted to achieve better results. This approach is called titration. Your child’s healthcare professional can determine which dose is right for your child. CONCERTA® has not been studied in children under age 6.

Over 53 million prescriptions have been written for CONCERTA®. With more than 9 years of proven safety, CONCERTA® has been studied in clinical trials in over 2,700 children and adolescents. And CONCERTA® is the #1 ADHD medication prescribed for children and adolescents with ADHD.

If your child has been diagnosed with ADHD, you’re not alone. You can find answers, help and hope. Ask your child’s healthcare professional about managing your child’s ADHD symptoms with CONCERTA®.

* The ABC Studies (Attention and Behavior with CONCERTA®) were two well-controlled studies that evaluated the efficacy of CONCERTA® for ADHD symptoms versus placebo in children aged 9-12 with ADHD in a classroom setting. The most common adverse events (>10%) in the ABC Clinical Trials were abdominal pain upper, irritability, decreased appetite, and headache.

** This survey was conducted online within the United States by Harris Interactive on behalf of McNeil PediatricsTM, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. between May 21 and June 2, 2008, among 150 adults who had a child aged 6–17 who had been diagnosed with ADHD and was taking CONCERTA® for more than 3 months at that time.

Is CONCERTA® Right For My Child?
Everyday activities can be a challenge when your child has ADHD. But making the decision to treat your child’s ADHD symptoms is an important first step. If your child has been diagnosed with ADHD, ask a healthcare professional how CONCERTA® can help your child manage ADHD symptoms.

With more than 9 years of proven safety, CONCERTA® is the #1 prescribed ADHD medication for children and adolescents with ADHD. CONCERTA® has been proven well tolerated in clinical studies of over 2,700 children and adolescents.

Methylphenidate, the medication in CONCERTA®, is recommended among first-line therapies by the American Academy of Pediatrics as part of a total treatment program for ADHD. Part of this includes a team of people focused on helping your child like family members, caregivers, teachers, and your child’s healthcare professional. This treatment approach may also include behavioral therapy.

In a study, teachers reported that children taking CONCERTA® showed improvement in ADHD symptoms as measured in areas such as focusing better, paying attention better, and completing projects that they started.

In clinical studies, CONCERTA® showed a positive effect on the important area of social interactions. In one study, parents of adolescents (aged 13-18) receiving CONCERTA® reported a decrease of 34% in conflict situations such as arguing or misbehaving when compared to placebo.

In another study with children aged 6-12, teachers reported improved peer interactions with children receiving CONCERTA® compared to placebo.

CONCERTA® has a low incidence of side effects. In clinical studies, less than 3% of children and adolescents experienced insomnia and less than 1% experienced a loss of appetite or moodiness. The most common adverse reaction was upper abdominal pain (5.9%).

If your child has been diagnosed with ADHD, ask his or her healthcare professional how treatment with CONCERTA® can help your child manage the everyday challenges of ADHD.

What to Expect from CONCERTA®
As a parent, you’ll want know what to expect from your child’s treatment with CONCERTA®. Every child is unique and will have his or her own response to ADHD medication. For your child to get the most out of treatment, it’s important to work closely with your child’s healthcare professional. It is also important to discuss any side effects with your child’s healthcare professional.

Your child only needs to take CONCERTA® once a day, in the morning, with or without food. CONCERTA® starts working at 1 hour and lasts through 12.5 hours, to provide long-lasting ADHD symptom control.* CONCERTA® offers a unique time-released formulation that provides all-day ADHD symptom control. CONCERTA® improves focus. And can help your child control his or her hyperactive and/or impulsive behavior.

CONCERTA® comes in a range of doses so your child can get the right amount to help manage his or her symptoms. Most children are started on 18 mg of CONCERTA®. But it may be necessary to adjust this dosage to get the best treatment results. This adjustment process is called titration. CONCERTA® is FDA approved in dosages up to 54 mg per day for children and 72 mg per day for adolescents. Children under 6 years of age should not take CONCERTA®.

A typical dose adjustment schedule may look like this:

Week 1: One 18-mg tablet once daily
Week 2: Two 18-mg tablets once daily for a total of 36 mg
Week 3: Three 18-mg tablets once daily for a total of 54 mg

During the first few weeks of treatment, it’s important that you and your child’s healthcare professional discuss how your child’s treatment is going. This may help your child quickly get to the dose that works best. Track your child’s symptoms to monitor his or her treatment progress. It’s also important to discuss any side effects with your child’s healthcare professional.

CONCERTA® should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; tics, Tourette’s syndrome, or family history of Tourette’s syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA®.

CONCERTA® has over 9 years of proven safety. But, like all ADHD medications, CONCERTA® has side effects. In studies of children and adolescents taking CONCERTA®:
Less than 3% of patients had trouble sleeping
Less than 1% had loss of appetite
Less than 1% experienced moodiness
The most common side effect was upper abdominal pain (5.9%)

Your child’s healthcare professional should check height and weight often and may interrupt CONCERTA® if your child is not growing or gaining weight as expected.

*The ABC Studies (Attention and Behavior with CONCERTA®) were two well-controlled studies that evaluated the efficacy of CONCERTA® for ADHD symptoms versus placebo in children aged 9-12 with ADHD in a classroom setting. The most common adverse events (>10%) in the ABC Clinical Trials were abdominal pain upper, irritability, decreased appetite, and headache.

The Value of Continued ADHD Treatment

ADHD symptoms can impact your child 7 days a week, at home, school and in social settings. The symptoms of ADHD don’t take a weekend or summer break. So, medication may be a necessary part of your child’s everyday routine.

If you’re considering a break from CONCERTA® during weekends, holidays, or summer vacation, you should first consult with your child’s healthcare professional before making any decision about treatment changes.

A guideline for ADHD treatment recommends that treatment should be continued as long as ADHD symptoms remain present and cause impairment. Stimulant medications, like CONCERTA®, only work as long as they are taken, so stopping treatment can result in the rapid return of symptoms.

Managing your child’s ADHD symptoms can improve his or her ability to focus and get along with others, even during breaks from school. Continued treatment with CONCERTA® may help your child have a better time managing his or her ADHD symptoms during weekend or summer activities like long car trips, organized sports, or summer camp.

In clinical studies, CONCERTA® showed a positive effect on the important area of social interactions. In one study, parents of adolescents (aged 13-18) receiving CONCERTA® reported a decrease of 34% in conflict situations such as arguing or misbehaving when compared to placebo.

In another study with children aged 6-12, teachers reported improved peer interactions with children receiving CONCERTA® compared to placebo.

CONCERTA® can help your child manage the daily challenges of ADHD symptoms. So, by continuing with once-daily CONCERTA® you could be providing important support to help your child maintain focus and improve his or her social interactions in less-structured environments.

Source: http://www.concerta.net

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How does Zeldox work? What will it do for me?

Ziprasidone belongs to the class of medications called antipsychotics. It is used to control the symptoms of schizophrenia and related mental health disorders. It works by adjusting the balance of chemicals in the brain that are involved in schizophrenia.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use Zeldox?

The usual starting dose of ziprasidone is 20 mg to 40 mg twice daily with food. The dose can be increased gradually every 2 days up to 80 mg twice daily, as recommended by the doctor. For maintenance treatment, the lowest dose needed to control symptoms should be used. The capsules should be swallowed whole with a glass of water.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of this medication by only a few hours, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication at room temperature, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does Zeldox come in?

20 mg

Each size No. 4 blue/white opaque hard gelatin capsule, imprinted in black with “Pfizer” and “396″ or “ZDX 20″, contains ziprasidone hydrochloride, monohydrate equivalent to 20 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

40 mg

Each size No. 4 blue/blue opaque hard gelatin capsule, imprinted in black with “Pfizer” and “397″ or “ZDX 40″, contains ziprasidone hydrochloride, monohydrate equivalent to 40 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

60 mg

Each size No. 3 white/white opaque hard gelatin capsule, imprinted in black with “Pfizer” and “398″ or “ZDX 60″, contains ziprasidone hydrochloride, monohydrate equivalent to 60 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

80 mg

Each size No. 2 blue/white opaque hard gelatin capsule, imprinted in black with “Pfizer” and “399″ or “ZDX 80″, contains ziprasidone hydrochloride, monohydrate equivalent to 80 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take Zeldox?

Ziprasidone should not be used by anyone who:

is allergic to ziprasidone or to any of the ingredients of the medication

is taking medications such as dofetilide, sotalol, quinidine, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, or any other medication that can cause QT prolongation

has or has a history of QT prolongation (including congenital long QT syndrome)

has recently had a heart attack

has severe heart failure

What side effects are possible with Zeldox?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain

agitation

constipation

diarrhea

dizziness

drowsiness

dry mouth

fatigue

flu-like symptoms

fungal skin infections

heartburn

increased cough

increased sun sensitivity

leakage of fluid or milk from breasts (women)

loss of appetite  menstrual changes

muscle aches

muscle stiffness or spasm

nausea or upset stomach

rash

respiratory tract infections

restlessness

runny nose

sensations that the room is spinning

sexual difficulties

slowness of movement

tremor

vision changes

vomiting

weakness

weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

abnormal movements of the face or tongue

abnormal walking

changes in body temperature, or feeling very hot and unable to cool down

chest pain

continuous erection

dizziness, especially when standing from a lying or seated position

high blood pressure

muscle twitching

painful eye movements

Stop taking the medication and seek immediate medical attention if any of the following occur:

abnormal heart rhythms (such as fast or slow heart rate, palpitations), fainting or seizures

confusion, reduced consciousness, high fever, or muscle stiffness

peeling or blistering skin

symptoms of a severe allergic reaction (itching, skin rash, shortness of breath, swelling of the face, lips, or tongue)

symptoms of a stoke such as sudden weakness or numbness of the face, arms, or legs (especially on one side); slurred speech; vision problems

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Zeldox?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, gatifloxacin, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, dolasetron mesylate, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with ziprasidone. You are more at risk for this type of abnormal heart rhythm and its complications if you:

are female

are older than 65 years of age

have a family history of sudden cardiac death

have a history of heart disease or abnormal hearth rhythms

have a slow heart rate

have congenital prolongation of the QT interval

have diabetes

have had a stroke

have low potassium, magnesium, or calcium levels

have nutritional deficiencies

Talk to your doctor about the risks and benefits of using this medication if you have any of these risk factors.

Blood sugar: This medication may cause high blood sugar levels. If you experience weakness, increased thirst, increased urination, and increased appetite while taking this medication, contact your doctor.

Body temperature: This medication, like other antipsychotic medications, can disrupt the body’s ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking this medication.

Drowsiness/reduced alertness: Ziprasidone may interfere with activities requiring mental alertness. People taking this medication should not drive or operate machinery until they know how this medication affects them.

Low blood pressure: Ziprasidone may cause low blood pressure when rising from a sitting or lying position. If you feel dizzy, lightheaded, or feel your pulse racing, or if you faint, call your doctor. While you are taking this medication, get up slowly if you have been sitting or lying down for a prolonged period.

Neuroleptic malignant syndrome (NMS): Ziprasidone, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Seizures: Ziprasidone may increase the risk of seizures, especially in people who have had seizures in the past. People who are at risk of seizures who take this medication should be closely monitored by their doctor.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the face and tongue muscles, may develop in people who take certain antipsychotic medications including ziprasidone. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if ziprasidone passes into breast milk. It is recommended that women taking this medication should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

Seniors: Medications similar to ziprasidone can increase the risk of death when used to treat seniors with dementia. Ziprasidone should not be used in seniors with dementia.

What other drugs could interact with Zeldox?

There may be an interaction between ziprasidone and any of the following:alcohol

amiodarone

arsenic trioxide

blood-pressure medications

carbamazepine

chlorpromazine

dolasetron mesylate

dopamine agonists (e.g., pramipexole, ropinirole)

droperidol

gatifloxacin

ketoconazole     levodopa

lithium

mefloquine

moxifloxacin

pentamidine

pimozide

probucol

procainamide

quinidine

sotalol

tacrolimus

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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Tablets 5 mg, 10 mg

THERAPEUTIC CLASSIFICATION

Anxiolytic-sedative

ACTIONS AND CLINICAL PHARMACOLOGY

‘Valium’ (diazepam) is an anxiolytic-sedative drug useful in the symptomatic relief of anxiety and tension states. It has also adjunctive value in the relief of certain neurospastic conditions.

ABSORPTION:

Diazepam is rapidly and completely absorbed from the gastrointestinal tract, peak plasma concentrations appearing 30-90 minutes after oral ingestion.

DISTRIBUTION:

Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). The volume of distribution at steady state is 0.8-1.0 L/kg. In humans, comparable blood levels of ‘Valium’ were obtained in maternal and cord blood indicating placental transfer of the drug.

METABOLISM:

Diazepam is mainly metabolized to the pharmacologically active metabolites such as N-desmethyldiazepam, temazepam and oxazepam.

ELIMINATION:

The acute half-life is six to eight hours with a slower decline thereafter (half-life up to 48 hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly in their conjugated forms. The clearance of diazepam is 20-30 mL/min.

PHARMACOKINETICS IN SPECIAL CLINICAL SITUATIONS :

The elimination half-life may be prolonged in the newborn, in the elderly and in patients with liver disease. In renal failure the half-life of diazepam is unchanged.

INDICATIONS

Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

‘Valium’ (diazepam) is useful in the symptomatic management of mild to moderate degrees of anxiety in conditions dominated by tension, excitation, agitation, fear or aggressiveness, such as may occur in:-psychoneurosis, anxiety reactions due to stress conditions and anxiety states with somatic expression. In acute alcoholic withdrawal, ‘Valium’ may be useful in the symptomatic relief of acute agitation, tremor and impending acute delirium tremens. ‘Valium’ is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology, such as inflammation of the muscle and joints or secondary to trauma; spasticity caused by upper motor neuron disorders, such as cerebral palsy and paraplegia; athetosis and the rare “stiff man syndrome”.

CONTRAINDICATIONS

‘Valium’ (diazepam) is contraindicated in patients with:

A known hypersensitivity to benzodiazepines, severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, myasthenia gravis and, because of lack of sufficient clinical experience, in children under six months of age.

WARNINGS

‘Vailum’ (diazepam) is not recommended in patients with dependence on other substances including alcohol. An exception to the latter is the management of acute withdrawal reactions.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression as suicide may occur in such patients.

PRECAUTIONS

Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.

A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.

TOLERANCE:

Some loss of response to the effects of benzodiazepines may develop after repeated use of ‘Valium’ (diazepam) for prolonged time.

DEPENDENCE:

Use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychological dependence. This risk of dependence increases with dose and duration of treatment (48,56,57]; it is also greater in predisposed patients with a history of alcohol or drug abuse.

WITHDRAWAL:

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

REBOUND ANXIETY:

A transient syndrome whereby the symptoms that led to treatment with ‘Valium’ recur in an enhanced form. This may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

AMNESIA:

It should be borne in mind that benzodiazepines may induce anterograde amnesia. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Effects of this may be associated with inappropriate behaviour.

PSYCHIATRIC AND ‘PARADOXICAL’ REACTIONS:

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, the use of the drug should be discontinued. They are more likely to occur in children and in the elderly.

USE IN ELDERLY:

Elderly and debilitated patients or those with organic brain disorders have been found to be prone to central nervous system depression following even low doses. For these patients it is recommended that the dosage be limited to the smallest, effective amount to preclude development of ataxia, over sedation or other possible adverse effects.

USE IN EPILEPTIC PATIENT:

Careful consideration should be given if ‘Valium’ is to be used in patients with epilepsy as the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the doses of standard anticonvulsant medication. An abrupt withdrawal of ‘Valium’ in such cases may also be associated with the temporary increase in the frequency and/or severity of seizures.

USE IN PREGNANCY AND NURSING:

The safety of diazepam for use in pregnancy has not been established. An increased risk of congenital malformation associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested. ‘Valium’ Injection should not be used during pregnancy except if absolutely necessary.

Continuous administration of benzodiazepines during pregnancy may give rise to hypotension, reduced respiratory function and hypothermia in the newborn child. Withdrawal symptoms in newborn infants have occasionally been reported with this class of drug. Special care must be taken when ‘Valium’ is used during labour and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia and moderate respiratory depression in the neonate. With new born infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).

Diazepam passes into breast milk. Breast-feeding is therefore not recommended in patients receiving ‘Valium’.

GENERAL:

Patients receiving ‘Valium’ should be advised to proceed cautiously wherever mental alertness and physical coordination are required. The usual precautions in treating patients with impaired renal and hepatic functions should be observed. If ‘Valium’ is administered for protracted periods, periodic blood counts and liver function tests would be highly advisable.

DRUG INTERACTIONS:

Careful consideration should be given if ‘Valium’ is to be combined with other centrally acting agents, such as (antipsychotics, anxiolytics/sedatives, antidepressants, hypnotics, anticonvulsants, narcotic analgesics, anesthetics and sedative antihistamines because the pharmacological action of these (84) agents might potentiate or be potentiated by the action of ‘Valium’. Since ‘Valium’ has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other central nervous system depressant drugs during ‘Valium’ therapy.

There is potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P 450 III A). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine and fluoxetine and omeprazole.

There have also been reports that the metabolic elimination of phenytoin is affected by diazepam.

Cisapride may lead to a temporary increase in the sedative effects of orally administered benzodiazepines due to faster absorption.

ADVERSE REACTIONS

The most common adverse reactions reported for ‘Valium’ (diazepam) are fatigue, drowsiness, muscle weakness and ataxia. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration.

The following may also occur: dizziness, nausea, dry mouth or hypersalivation, blurred vision, diplopia, headache, slurred speech, tremors, dysarthria, confusion, depression, incontinence or urinary retention, constipation, gastrointestinal disturbances, skin rash, generalized exfoliative dermatitis, hypotension and changes in libido; very rarely, elevated transaminases and alkaline phosphatase have been reported occasionally.

Other reactions noted less frequently are vertigo, hypoactivity, euphoria and impairment of memory.

Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.

Effects of this be associated with inappropriate behaviour.

The more serious adverse reactions occasionally reported are leucopenia, jaundice and hypersensitivity.

PSYCHIATRIC AND ‘PARADOXICAL’ REACTIONS:

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines . Should these occur, the drug should be discontinued. They are more likely to occur in children and in the elderly.

Minor changes in EEG patterns have been observed in patients on. ‘Valium’ therapy. These changes consist of low to moderate voltage fast activity, 20 to 30 cycles per second and are of no known significance.

Chronic use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena.

Abuse of benzodiazepines has been reported.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

SYMPTOMS

The main symptoms of overdosage are drowsiness, over sedation and ataxia. When the effects of the drug overdosage begin to wear off, the patient exhibits some jitteriness and overstimulation. The cardinal manifestations of overdosage are drowsiness and confusion, reduced reflexes and coma (rarely) and death (very rarely). However, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). There are minimum effects on respiration, pulse and blood pressure unless the overdosage is extreme.

TREATMENT

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken. Vomiting should be induced (within 1 hour) if the patient is conscious or gastric lavage, with the airway protected if the patient is unconscious, may be beneficial if performed soon after oral ingestion of ‘Valium’ (diazepam). If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. If necessary, a CNS stimulant such as caffeine or methylphenidate may be administered with caution. Supportive measures should be instituted as indicated:- maintenance of an adequate airway, levarterenol or metaraminol bitartrate for hypotension. Flumazenil may be useful as an antagonist. Caution should be observed in the use of flumazenil in epileptics treated with benzodiazepines. Dialysis appears to be of little value.

DOSAGE AND ADMINISTRATION

Dosage for ‘Valium’ (diazepam) should be individualized for maximal beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In the first few days of administration a cumulative effect of drug may occur, and therefore, the dosage should be increased only after stabilization is apparent.

DURATION OF TREATMENT

The duration of treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment evaluated, especially if the patient is symptom free. It should not exceed 2- 3 months, including the tapering-off period. Extension beyond this period should not take place without reevaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur during withdrawal. There is evidence that, in the case of shortacting benzodiazepines, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. When long-acting benzodiazepines such as diazepam are being used, it is important to warn against changing to a short-acting benzodiazepine as withdrawal symptoms may develop.

USUAL DAILY DOSE

ADULTS:

Symptomatic relief of anxiety and tension in psychoneurosis and anxiety reactions:Depending upon severity of symptoms – 2 mg to 10 mg, two to four times daily.

Symptomatic relief in acute alcohol withdrawal: 10 mg, three or four times during timehe first 24 hours, reducing to 5 mg, three or four ts daily as needed.

Adjunctively for relief of skeletal muscle spasm: 2 mg to 10 mg, three to four times daily.

Elderly and debilitated patients, or in thepresence of debilitating disease: 2 mg, one or two times daily initially, increase gradually as needed and tolerated

CHILDREN:

Because of varied responses, initiate therapy with lowest dose and increase as required. Not for use in children under six months. (See Contraindications):  1 mg to 2½ mg, three or four times daily initially; increase gradually as needed and tolerated.

PHARMACEUTICAL INFORMATION

CHEMISTRY: ‘Valium’ contains as active substance diazepam (7-chloro- 1, 3-dihydro-l-methyl-5-phenyl-2H-1, 4-benzodiazepine-2- one), a benzodiazepine derivative. It is a colorless, crystalline compound, insoluble in water and has a molecular weight of 284.74.

STRUCTURAL FORMULA

COMPOSITION: ‘Valium’ is available for oral administration as tablets containing 5 mg of diazepam. Non-medicinal ingredients are corn starch, iron oxide yellow, lactose and magnesium stearate.

AVAILABILITY OF DOSAGE FORMS

‘Valium’ (diazepam) Scored Tablets: 5 mg, yellow; and 10 mg, blue.

PRESCRIBING INFORMATION

VALIUM® ROCHE®

(diazepam)

Tablets

5 mg, 10 mg

ANXIOLYTIC-SEDATIVE

HOFFMANN-LA ROCHE LIMITED DATE OF PREPARATION:

2455 Meadowpine Boulevard December 18, 1969

MISSISSAUGA, ONTARIO L5N 6L7

Date of Revision:

March 12, 1998

®Registered Trademark

Copyright 1998 – Hoffmann-La Roche Ltd.

CAN 6053

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The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

Schizophrenia affects about 1 percent of the U.S. population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and suspiciousness. Hearing voices that other people don’t hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.”

Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.

Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, N.J.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm

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In the 1990′s, new antipsychotic medications were developed. These new medications are called second generation, or “atypical” antipsychotics.

One of these medications, clozapine (Clozaril) is an effective medication that treats psychotic symptoms, hallucinations, and breaks with reality. But clozapine can sometimes cause a serious problem called agranulocytosis, which is a loss of the white blood cells that help a person fight infection. People who take clozapine must get their white blood cell counts checked every week or two. This problem and the cost of blood tests make treatment with clozapine difficult for many people. But clozapine is potentially helpful for people who do not respond to other antipsychotic medications.19

Other atypical antipsychotics were also developed. None cause agranulocytosis. Examples include:
Risperidone (Risperdal)
Olanzapine (Zyprexa)
Quetiapine (Seroquel)
Ziprasidone (Geodon)
Aripiprazole (Abilify)
Paliperidone (Invega).
When a doctor says it is okay to stop taking a medication, it should be gradually tapered off, never stopped suddenly.

What are the side effects?

Some people have side effects when they start taking these medications. Most side effects go away after a few days and often can be managed successfully. People who are taking antipsychotics should not drive until they adjust to their new medication. Side effects of many antipsychotics include:
Drowsiness
Dizziness when changing positions
Blurred vision
Rapid heartbeat
Sensitivity to the sun
Skin rashes
Menstrual problems for women.

Atypical antipsychotic medications can cause major weight gain and changes in a person’s metabolism. This may increase a person’s risk of getting diabetes and high cholesterol.20 A person’s weight, glucose levels, and lipid levels should be monitored regularly by a doctor while taking an atypical antipsychotic medication.

Typical antipsychotic medications can cause side effects related to physical movement, such as:
Rigidity
Persistent muscle spasms
Tremors
Restlessness.

Long-term use of typical antipsychotic medications may lead to a condition called tardive dyskinesia (TD). TD causes muscle movements a person can’t control. The movements commonly happen around the mouth. TD can range from mild to severe, and in some people the problem cannot be cured. Sometimes people with TD recover partially or fully after they stop taking the medication.

TD happens to fewer people who take the atypical antipsychotics, but some people may still get TD. People who think that they might have TD should check with their doctor before stopping their medication.

How are antipsychotics taken and how do people respond to them?

Antipsychotics are usually in pill or liquid form. Some anti-psychotics are shots that are given once or twice a month.

Symptoms of schizophrenia, such as feeling agitated and having hallucinations, usually go away within days. Symptoms like delusions usually go away within a few weeks. After about six weeks, many people will see a lot of improvement.

However, people respond in different ways to antipsychotic medications, and no one can tell beforehand how a person will respond. Sometimes a person needs to try several medications before finding the right one. Doctors and patients can work together to find the best medication or medication combination, as well as the right dose.

Some people may have a relapse-their symptoms come back or get worse. Usually, relapses happen when people stop taking their medication, or when they only take it sometimes. Some people stop taking the medication because they feel better or they may feel they don’t need it anymore. But no one should stop taking an antipsychotic medication without talking to his or her doctor. When a doctor says it is okay to stop taking a medication, it should be gradually tapered off, never stopped suddenly.

How do antipsychotics interact with other medications?

Antipsychotics can produce unpleasant or dangerous side effects when taken with certain medications. For this reason, all doctors treating a patient need to be aware of all the medications that person is taking. Doctors need to know about prescription and over-the-counter medicine, vitamins, minerals, and herbal supplements. People also need to discuss any alcohol or other drug use with their doctor.

To find out more about how antipsychotics work, the National Institute of Mental Health (NIMH) funded a study called CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness). This study compared the effectiveness and side effects of five antipsychotics used to treat people with schizophrenia. In general, the study found that the older typical antipsychotic perphenazine (Trilafon) worked as well as the newer, atypical medications. But because people respond differently to different medications, it is important that treatments be designed carefully for each person. More information about CATIE is on the NIMH website.

Psychosocial treatments

Psychosocial treatments can help people with schizophrenia who are already stabilized on antipsychotic medication. Psychosocial treatments help these patients deal with the everyday challenges of the illness, such as difficulty with communication, self-care, work, and forming and keeping relationships. Learning and using coping mechanisms to address these problems allow people with schizophrenia to socialize and attend school and work.

Patients who receive regular psychosocial treatment also are more likely to keep taking their medication, and they are less likely to have relapses or be hospitalized. A therapist can help patients better understand and adjust to living with schizophrenia. The therapist can provide education about the disorder, common symptoms or problems patients may experience, and the importance of staying on medications. For more information on psychosocial treatments, see the psychotherapies section on the NIMH website.

Illness management skills. People with schizophrenia can take an active role in managing their own illness. Once patients learn basic facts about schizophrenia and its treatment, they can make informed decisions about their care. If they know how to watch for the early warning signs of relapse and make a plan to respond, patients can learn to prevent relapses. Patients can also use coping skills to deal with persistent symptoms.

Integrated treatment for co-occurring substance abuse. Substance abuse is the most common co-occurring disorder in people with schizophrenia. But ordinary substance abuse treatment programs usually do not address this population’s special needs. When schizophrenia treatment programs and drug treatment programs are used together, patients get better results.

Rehabilitation. Rehabilitation emphasizes social and vocational training to help people with schizophrenia function better in their communities. Because schizophrenia usually develops in people during the critical career-forming years of life (ages 18 to 35), and because the disease makes normal thinking and functioning difficult, most patients do not receive training in the skills needed for a job.

Rehabilitation programs can include job counseling and training, money management counseling, help in learning to use public transportation, and opportunities to practice communication skills. Rehabilitation programs work well when they include both job training and specific therapy designed to improve cognitive or thinking skills. Programs like this help patients hold jobs, remember important details, and improve their functioning.21,22,23

Family education. People with schizophrenia are often discharged from the hospital into the care of their families. So it is important that family members know as much as possible about the disease. With the help of a therapist, family members can learn coping strategies and problem-solving skills. In this way the family can help make sure their loved one sticks with treatment and stays on his or her medication. Families should learn where to find outpatient and family services.

Cognitive behavioral therapy. Cognitive behavioral therapy (CBT) is a type of psychotherapy that focuses on thinking and behavior. CBT helps patients with symptoms that do not go away even when they take medication. The therapist teaches people with schizophrenia how to test the reality of their thoughts and perceptions, how to “not listen” to their voices, and how to manage their symptoms overall. CBT can help reduce the severity of symptoms and reduce the risk of relapse.

Self-help groups. Self-help groups for people with schizophrenia and their families are becoming more common. Professional therapists usually are not involved, but group members support and comfort each other. People in self-help groups know that others are facing the same problems, which can help everyone feel less isolated. The networking that takes place in self-help groups can also prompt families to work together to advocate for research and more hospital and community treatment programs. Also, groups may be able to draw public attention to the discrimination many people with mental illnesses face.
Once patients learn basic facts about schizophrenia and its treatment, they can make informed decisions about their care.

Source: http://www.nimh.nih.gov

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In 2002, the FDA approved the nonstimulant medication atomoxetine (Strattera) for use as a treatment for ADHD. In February 2007, the FDA approved the use of the stimulant lisdexamfetamine dimesylate (Vyvanse) for the treatment of ADHD in children ages 6 to 12 years.
What are the side effects?
Most side effects are minor and disappear when dosage levels are lowered. The most common side effects include:
Decreased appetite. Children seem to be less hungry during the middle of the day, but they are often hungry by dinnertime as the medication wears off.
Sleep problems. If a child cannot fall asleep, the doctor may prescribe a lower dose. The doctor might also suggest that parents give the medication to their child earlier in the day, or stop the afternoon or evening dose. To help ease sleeping problems, a doctor may add a prescription for a low dose of an antidepressant or a medication called clonidine.
Stomachaches and headaches.
Less common side effects. A few children develop sudden, repetitive movements or sounds called tics. These tics may or may not be noticeable. Changing the medication dosage may make tics go away. Some children also may appear to have a personality change, such as appearing “flat” or without emotion. Talk with your child’s doctor if you see any of these side effects.
How are ADHD medications taken?

Stimulant medications can be short-acting or long-acting, and can be taken in different forms such as a pill, patch, or powder. Long-acting, sustained and extended release forms allow children to take the medication just once a day before school. Parents and doctors should decide together which medication is best for the child and whether the child needs medication only for school hours or for evenings and weekends too.

ADHD medications help many children and adults who are hyperactive and impulsive. They help people focus, work, and learn. Stimulant medication also may improve physical coordination. However, different people respond differently to medications, so children taking ADHD medications should be watched closely.
Are ADHD medications safe?
Stimulant medications are safe when given under a doctor’s supervision. Some children taking them may feel slightly different or “funny.”

Some parents worry that stimulant medications may lead to drug abuse or dependence, but there is little evidence of this. Research shows that teens with ADHD who took stimulant medications were less likely to abuse drugs than those who did not take stimulant medications.14
FDA warning on possible rare side effects

In 2007, the FDA required that all makers of ADHD medications develop Patient Medication Guides. The guides must alert patients to possible heart and psychiatric problems related to ADHD medicine. The FDA required the Patient Medication Guides because a review of data found that ADHD patients with heart conditions had a slightly higher risk of strokes, heart attacks, and sudden death when taking the medications. The review also found a slightly higher risk (about 1 in 1,000) for medication-related psychiatric problems, such as hearing voices, having hallucinations, becoming suspicious for no reason, or becoming manic. This happened to patients who had no history of psychiatric problems.

The FDA recommends that any treatment plan for ADHD include an initial health and family history examination. This exam should look for existing heart and psychiatric problems.

The non-stimulant ADHD medication called atomoxetine (Strattera) carries another warning. Studies show that children and teenagers with ADHD who take atomoxetine are more likely to have suicidal thoughts than children and teenagers with ADHD who do not take atomoxetine. If your child is taking atomoxetine, watch his or her behavior carefully. A child may develop serious symptoms suddenly, so it is important to pay attention to your child’s behavior every day. Ask other people who spend a lot of time with your child, such as brothers, sisters, and teachers, to tell you if they notice changes in your child’s behavior. Call a doctor right away if your child shows any of the following symptoms:
Acting more subdued or withdrawn than usual
Feeling helpless, hopeless, or worthless
New or worsening depression
Thinking or talking about hurting himself or herself
Extreme worry
Agitation
Panic attacks
Trouble sleeping
Irritability
Aggressive or violent behavior
Acting without thinking
Extreme increase in activity or talking
Frenzied, abnormal excitement
Any sudden or unusual changes in behavior.

While taking atomoxetine, your child should see a doctor often, especially at the beginning of treatment. Be sure that your child keeps all appointments with his or her doctor.

Source: http://www.nimh.nih.gov

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Depression is a serious disorder that can cause significant problems in mood, thinking, and behavior at home, in school, and with peers. It is estimated that major depressive disorder (MDD) affects about 5 percent of adolescents.

Research has shown that, as in adults, depression in children and adolescents is treatable. Certain antidepressant medications, called selective serotonin reuptake inhibitors (SSRIs), can be beneficial to children and adolescents with MDD. Certain types of psychological therapies also have been shown to be effective. However, our knowledge of antidepressant treatments in youth, though growing substantially, is limited compared to what we know about treating depression in adults.

Recently, there has been some concern that the use of antidepressant medications themselves may induce suicidal behavior in youths. Following a thorough and comprehensive review of all the available published and unpublished controlled clinical trials of antidepressants in children and adolescents, the U.S. Food and Drug Administration (FDA) issued a public warning in October 2004 about an increased risk of suicidal thoughts or behavior (suicidality) in children and adolescents treated with SSRI antidepressant medications. In 2006, an advisory committee to the FDA recommended that the agency extend the warning to include young adults up to age 25.

More recently, results of a comprehensive review of pediatric trials conducted between 1988 and 2006 suggested that the benefits of antidepressant medications likely outweigh their risks to children and adolescents with major depression and anxiety disorders. The study, partially funded by NIMH, was published in the April 18, 2007, issue of the Journal of the American Medical Association.1

What Did the FDA Review Find?

In the FDA review, no completed suicides occurred among nearly 2,200 children treated with SSRI medications. However, about 4 percent of those taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts—twice the rate of those taking placebo, or sugar pills.

In response, the FDA adopted a “black box” label warning indicating that antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents with MDD. A black-box warning is the most serious type of warning in prescription drug labeling.

The warning also notes that children and adolescents taking SSRI medications should be closely monitored for any worsening in depression, emergence of suicidal thinking or behavior, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment. SSRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.
What Do We Know About Antidepressant Medications?

The SSRIs include:
fluoxetine (Prozac)
sertraline (Zoloft)
paroxetine (Paxil)
citalopram (Celexa)
escitalopram (Lexapro)
fluvoxamine (Luvox)

Another antidepressant medication, venlafaxine (Effexor), is not an SSRI but is closely related.

SSRI medications are considered an improvement over older antidepressant medications because they have fewer side effects and are less likely to be harmful if taken in an overdose, which is an issue for patients with depression already at risk for suicide. They have been shown to be safe and effective for adults.

However, use of SSRI medications among children and adolescents ages 10 to 19 has risen dramatically in the past several years. Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older. The other SSRI medications and the SSRI-related antidepressant venlafaxine have not been approved for treatment of depression in children or adolescents, but doctors still sometimes prescribe them to children on an “off-label” basis. In June 2003, however, the FDA recommended that paroxetine not be used in children and adolescents for treating MDD.

Fluoxetine can be helpful in treating childhood depression, and can lead to significant improvement of depression overall. However, it may increase the risk for suicidal behaviors in a small subset of adolescents. As with all medical decisions, doctors and families should weigh the risks and benefits of treatment for each individual patient.

What Should You Do for a Child With Depression?

A child or adolescent with MDD should be carefully and thoroughly evaluated by a doctor to determine if medication is appropriate. Psychotherapy often is tried as an initial treatment for mild depression. Psychotherapy may help to determine the severity and persistence of the depression and whether antidepressant medications may be warranted. Types of psychotherapies include “cognitive behavioral therapy,” which helps people learn new ways of thinking and behaving, and “interpersonal therapy,” which helps people understand and work through troubled personal relationships.

Those who are prescribed an SSRI medication should receive ongoing medical monitoring. Children already taking an SSRI medication should remain on the medication if it has been helpful, but should be carefully monitored by a doctor for side effects. Parents should promptly seek medical advice and evaluation if their child or adolescent experiences suicidal thinking or behavior, nervousness, agitation, irritability, mood instability, or sleeplessness that either emerges or worsens during treatment with SSRI medications.

Once started, treatment with these medications should not be abruptly stopped. Although they are not habit-forming or addictive, abruptly ending an antidepressant can cause withdrawal symptoms or lead to a relapse. Families should not discontinue treatment without consulting their doctor.

All treatments can be associated with side effects. Families and doctors should carefully weigh the risks and benefits, and maintain appropriate follow-up and monitoring to help control for the risks.

What Does Research Tell Us?

An individual’s response to a medication cannot be predicted with certainty. It is extremely difficult to determine whether SSRI medications increase the risk for completed suicide, especially because depression itself increases the risk for suicide and because completed suicides, especially among children and adolescents, are rare. Most controlled trials are too small to detect for rare events such as suicide (thousands of participants are needed). In addition, controlled trials typically exclude patients considered at high risk for suicide.

One major clinical trial, the NIMH-funded Treatment for Adolescents with Depression Study (TADS)2, has indicated that a combination of medication and psychotherapy is the most effective treatment for adolescents with depression. The clinical trial of 439 adolescents ages 12 to 17 with MDD compared four treatment groups—one that received a combination of fluoxetine and CBT, one that received fluoxetine only, one that received CBT only, and one that received a placebo only. After the first 12 weeks, 71 percent responded to the combination treatment of fluoxetine and CBT, 61 percent responded to the fluoxetine only treatment, 43 percent responded to the CBT only treatment, and 35 percent responded to the placebo treatment.

At the beginning of the study, 29 percent of the TADS participants were having clinically significant suicidal thoughts. Although the rate of suicidal thinking decreased among all the treatment groups, those in the fluoxetine/CBT combination treatment group showed the greatest reduction in suicidal thinking.

Researchers are working to better understand the relationship between antidepressant medications and suicide. So far, results are mixed. One study, using national Medicaid files, found that among adults, the use of antidepressants does not seem to be related to suicide attempts or deaths. However, the analysis found that the use of antidepressant medications may be related to suicide attempts and deaths among children and adolescents.3

Another study analyzed health plan records for 65,103 patients treated for depression.4 It found no significant increase among adults and young people in the risk for suicide after starting treatment with newer antidepressant medications.

A third study analyzed suicide data from the National Vital Statistics and commercial prescription data. It found that among children ages five to 14, suicide rates from 1996 to 1998 were actually lower in areas of the country with higher rates of SSRI antidepressant prescriptions. The relationship between the suicide rates and the SSRI use rates, however, is unclear.5

New NIMH-funded research will help clarify the complex interplay between suicide and antidepressant medications. In addition, the NIMH-funded Treatment of Resistant Depression in Adolescents (TORDIA) study, will investigate how best to treat adolescents whose depression is resistant to the first SSRI medication they have tried. Finally, NIMH also is supporting the Treatment of Adolescent Suicide Attempters (TASA) study, which is investigating the treatment of adolescents who have attempted suicide. Treatments include antidepressant medications, CBT or both.

Complete list of all NIMH Clinical Trials.
Bridge JA, Iyengar S, Salary CB, Barbe RP, Birmaher B, Pincus HA, Ren L, Brent DA, MD. Clinical Response and Risk for Reported Suicidal Ideation and Suicide Attempts in Pediatric Antidepressant Treatment: A Meta-analysis of Randomized Controlled Trials. JAMA. 2007;297:1683-1696.
Treatment for Adolescents with Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial. Journal of the American Medical Association, 2004 Aug 18; 292(7):807-20.
Olfson M, Marcus SC, Shaffer D. Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults. Archives of General Psychiatry. 2006 Aug. 63:865-72
Simon GE, Savarino J, Operskalski B, Wang P. Suicide Risk During Antidepressant Treatment. American Journal of Psychiatry. 2006. 163 (1): 41-47.
Gibbons RD, Hur K, Bhaumik DK, Mann JJ. The relationships between antidepressant prescription rates and rate of early adolescent suicide. American Journal of Psychiatry 2006. 163 (11): 1898-1904
Source: http://www.nimh.nih.gov

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THE AUTHOR, Lawrence Stevens, is a lawyer whose practice has included representing psychiatric “patients”. His pamphlets are not copyrighted. You are encouraged to make copies for distribution to those who you think will benefit.

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If you need specific advice about how to stop taking one or more psychiatric drugs, this is the book to read. In this respect, this book fills in a gap left in other books by Dr. Peter Breggin I have read, including Psychiatric Drugs: Hazards to the Brain (1983), Toxic Psychiatry (1991), and Talking Back to Prozac (1998). In this book Drs. Breggin & Cohen also make clear they think the concept of “mental illness” is erroneous. For example, they repeatedly put the term mental illness in mocking quotation marks. They state clearly that in their opinion you are better off without psychiatric drugs, whatever your “psychiatric problem” may be: depression, manic-depressive mood swings, anxiety attacks, “schizophrenia” or psychosis, or anything else.
In this book Drs. Breggin & Cohen review the reasons you should not be taking any kind of psychiatric drug:
“No psychiatric drug has ever been tailored to a known biochemical derangement. … no biochemical imbalances have ever been documented with certainty in association with any psychiatric diagnosis. The hunt goes on for these illusive imbalances; but their existence is pure speculation, inspired by those who advocate drugs” (p. 35).
“Although medication advocates often speak with seeming confidence about how psychiatric drugs can correct biochemical imbalances in the brain, they are merely indulging in pure speculation. There’s little evidence for the existence of any such imbalances and no way to demonstrate how drugs would affect them if they did exist” (p. 34).
“Often, patients are told, ‘It’s biological and genetic.’ Never mind that there’s no substantial evidence that any psychiatric diagnoses have a physical basis” (p. 93).
“Precisely because there is so little scientific backing for the use of psychiatric drugs, mystification and slogans are often communicated to doctors by drug advertising, and then to patients by doctors” (p. 112-123, underline added).
“Indeed, we should suspect that any psychoactive drug – any drug that affects mental function – tends to produce irreversible changes in some if not most people. What hope can we have that bathing the brain in a psychiatric drug will actually improve the overall function of this mysterious organ? Almost none. In fact … most of what we know about the various neurotransmitters has been gathered by studying how psychiatric drugs disrupt or spoil their functioning” (p. 9 – underline added).
“Advocates of psychiatric drugs often claim that the medications improve learning and the ability to benefit from psychotherapy, but the contrary is true. There are no drugs that improve mental function, self-understanding, or human relations. Any drug that affects mental processes does so by impairing them” (p. 97-98).
“Despite a hugely successful promotional campaign by drug companies and biological psychiatry, the effectiveness of most or all psychiatric drugs remains difficult to demonstrate. The drugs often prove no more effective than sugar pills, or placebos – and to accomplish even these limited positive results, the clinical trials and data that they generate typically have to be statistically manipulated” (p. 37).
“But isn’t psychiatry science? Isn’t faith in psychiatry based on facts? On research? Can’t we ‘trust in research’? The sad truth is that, in the field of psychiatry, it is impossible to ‘trust in research.’ Nearly all of the research in this field is paid for by drug companies and conducted by people who will ‘deliver’ in the best way possible for those companies. … Sadly, even well-informed people too often put their faith in psychiatry and psychiatric research. It is the same as putting their faith in a drug company” (p. 189-190).
“…emotional suffering cannot be dulled without harming other functions such as concentration, alertness, sensitivity, and self-awareness” (p. 36).
“All psychiatric drugs can cause problems during withdrawal” (p. 16). And the longer you take a psychiatric drug, the more difficult your withdrawal will be.
“…many adverse drug effects are difficult to distinguish from emotional problems” (p. 24).
“Contrary to claims, neuroleptics have no specific effects on irrational ideas (delusions) or perceptions (hallucinations). Like all other psychiatric drugs, they have the same impact on healthy animals, healthy volunteers, and patients – namely, the production of apathy and indifference” (p. 77).
Neuroleptic drugs cause brain damage evidenced by a movement disorder called tardive dyskinesia, but “Neuroleptics actually suppress the symptoms of tardive dyskinesia while the disease is developing. … The rates of TD [tardive dyskinesia] are extremely high. Many standard textbooks estimate a rate of 5% – 7% per year in healthy young adults [who are taking neuroleptic drugs]. The rate is cumulative so that 25% – 35% of patients [taking neuroleptics] will develop the disorder in 5 years of treatment. Among the elderly [taking neuroleptics], rates of TD reach 20% or more per year. For a variety of reasons, including the failure to include tardive akathisia in estimates, the actual rates are probably much higher for all patients” (p. 78).
So-called antipsychotic or neuroleptic drugs cause a fatal disease called neuroleptic malignant syndrome in up to 2.4% of people taking them. “Using a low-end rate of 1 percent, Maxmen and Ward (1995, p. 33) estimate that 1,000 – 4,000 deaths occur in America each year as a result of neuroleptic malignant syndrome. The actual number is probably much greater” (p. 79).
Neuroleptic, also known as antipsychotic or major tranquilizer drugs “subject almost every system in the body to impairment. Research, including a recent study, indicates that these drugs are toxic to cells in general” (p. 81).
Clozaril … was banned in some European countries because it caused so many fatalities; but the escalating power of drug companies subsequently led to its approval by the FDA” in the United States (p. 82).
If you are pregnant, psychiatric drugs you take will cross into the baby’s bloodstream “and from there, to enter the unborn infant’s brain. Similarly, psychiatric drugs enter the mother’s milk and thus also affects the nursing infant’s brain” (p. 26).
“…women who take lithium during pregnancy expose their infants to an increased rate of heart defects” (p. 26).
“Some physicians try to reassure pregnant or nursing mothers about their baby’s safety while they are taking psychiatric drugs. But there is no scientific basis for offering this reassurance in regard to any drug that affects the brain” (p. 84).
This book is a well-documented, well-written, recent (1999), exposé of the health care quackery called biological psychiatry, particularly psychiatric drugs.
On specifically how to go about stopping taking psychiatric drugs, Drs. Breggin & Cohen say “The general rule recommended by some practitioners is to taper off in 10 percent decrements – usually every seven to ten days” (p. 126). That means you do it in ten separate steps. They suggest the last ten percent may need to be divided into a series of smaller steps and that if you are an older person who has “been taking tranquilizers daily for over twenty years … a withdrawal period of two years is not unusual” (p. 137). If you are taking more than one psychiatric drug each day, they recommend going off the drugs one at a time, that is, continuing your usual dose of your other drugs while you taper off one of them. How do you decide which drug to discontinue first? They say if “you’re taking drug ‘A’ to counteract the side effects of drug ‘B’ … you should probably start withdrawal with drug ‘B’” (p. 136). While they recommend you withdraw from psychiatric drugs with the help of a health care professional, they acknowledge that “most people who come off psychiatric drugs have successfully done so on their own, without active clinical supervision” (p. 113 – italics in original).
I was disappointed to find nothing in this book about a problem that is central to the subject of the book: forced psychiatric drugging of imprisoned or “hospitalized” persons, and the enactment of forced outpatient psychiatric drugging laws in the majority of the states of the U.S.A., exemplified by Kendra’s Law in New York. Like many of us in the ex-patient’s or “psychiatric survivor’s” movement, I was once imprisoned or “hospitalized” and forced to take a psychiatric drug – Thorazine. I was psychologically entirely normal at the time, even if I was very unhappy about the loss of the relationship with the woman I loved and about being on scholastic probation in college, leading to my parents deciding to force me into what they mistakenly thought would be “therapy”: Since I refused to seek “therapy” voluntarily, their only way to force me into “therapy” was committing me to a “hospital” against my will. The day I was incarcerated (or “hospitalized”), after the hospital staff got through asking me questions for their paperwork, I was permitted to walk around awhile in the hallways and rooms in the place I’d been imprisoned, exploring my new surroundings. But for no apparent reason, after awhile a nurse approached me with a hypodermic needle in her hand and told me she had a shot for me my doctor had prescribed for me. “I haven’t even seen a doctor” I told her. She seemed to realize I was correct, and she looked a little embarrassed when I asked the name of the doctor who had supposedly ordered the shot: She had no idea who he was. But none of that mattered to the hospital staff. She went away but was back a little while later with a large orderly, later joined by another, to force me to submit to the injection. They also did not care when I told them I hadn’t yet had a hearing or trial to determine if my commitment was justified or not, that I was being held only on a pretrial commitment order, and that it was wrong for them to force me to take a drug before I’d had a chance to go to court to present my arguments against committing or “treating” me against my will. Because of involuntary “hospitalization” laws in every state, and “outpatient commitment” laws in 40 or more states of the U.S.A. that exist for the purpose of forcing people to take psychiatric drugs or face repeated imprisonment in psychiatric “hospitals,” those of us who because of our past experience of it fear forced administration of these harmful drugs need advice about how to protect ourselves from it. All Drs. Breggin & Cohen say on this subject is: “Do not let anyone pressure you into starting or continuing psychiatric drugs. As a competent adult, you have the ethical and legal right to make your own decisions about taking psychiatric drugs. … Your decisions about taking or rejecting drugs need to be made without coercive pressure from doctors” (p. 29). While I agree with this statement, it is obvious many, apparently most, state legislators, judges, psychiatrists, and psychiatric hospital staff members do not. What us victims of psychiatry need is a strategy for avoiding forced psychiatric drugging. Drs. Breggin & Cohen do not offer one in this book.
There may not be a reliable way to protect yourself from forced psychiatric drugging, but here are two ideas: One is to hire a lawyer to write a “Declaration Regarding Mental Health Treatment,” also known as an “advance directive,” in which you say you want to receive no psychiatric drugs (or physical restraint or shock treatment) if you ever are declared mentally ill or incompetent, with a certification by a psychiatrist attached stating that you were mentally competent at the time you made the Declaration. This will undermine the argument that you would consent to “treatment” if only your thinking were not clouded by mental illness. Another strategy is to maintain a relationship with a psychiatrist who opposes coercive “treatment” who will testify for you if you become a victim of psychiatric oppression such as forced “hospitalization” or psychiatric assault such as forced psychiatric drugging. A lawyer recently advised me it probably needs to be a psychiatrist, not a psychologist. Perhaps in states where psychologists are permitted to commit people against their will, a psychologist’s testimony would be adequate.
In a rational world where human rights were respected, forced psychiatric drugging would not happen. In a rational world where human rights were respected, none of today’s psychiatric drugs would be used by anyone, voluntarily or involuntarily. Perhaps books like Your Drug May Be Your Problem will help some of us start thinking rationally about psychiatric drugs.
by
Peter R. Breggin, M.D. & David Cohen, Ph.D.
Perseus Books – Reading, Massachusetts – 1999
reviewed by Douglas A. Smith
Source: http://www.antipsychiatry.org/br-ydmby.htm

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When was the SSRI discontinuation syndrome first recognized?

Reports began to emerge soon after the SSRIs were introduced in the late 1980s.

How common is it? The incidence and prevalence of this syndrome is not yet known. The few available discontinuation studies indicate minor forms of the syndrome may be common and severe forms unusual. A retrospective chart review of 171 clinic patients who discontinued an SSRI while under supervision, reported at least one new symptom in 20% and 14% of patients stopping paroxetine (Paxil) and fluvoxamine (Luvox), respectively. Abrupt discontinuation of fluvoxamine was associated with new symptoms in 12 of 14 subjects (86%) in a prospective, open-label panic study. In a randomized placebo-controlled trial of paroxetine for panic, 19/55 (34%) experienced withdrawal symptoms. Abrupt discontinuation of fluoxetine (Prozac) in a randomized placebo controlled study of 299 subjects did not appear to cause many symptoms. No published study of sertraline (Zoloft) discontinuation symptoms is yet available but there are several case reports.

What are the signs and symptoms of the SSRI discontinuation syndrome?

Neurologic symptoms (dizziness, vertigo, lightheadedness and gait instability) are most commonly reported, followed by somatic complaints (nausea, emesis, fatigue and headache) and not uncommonly, insomnia. Still characteristic but reported less frequently are shock-like sensations, parasthesia, visual disturbances, diarrhea, myalgias and chills. A range of nonspecific mental symptoms including agitation, impaired concentration, vivid dreams, depersonalization, irritability and suicidal thoughts have been reported. When allowed to run its course, the syndrome duration is variable (one to several weeks) and ranges from mild-moderate intensity in most patients, to extremely distressing in a small number.

What other factors should clinicians consider when identifing this syndrome?

The duration of SSRI use is usually 1 month with symptoms developing 2-5 days after SSRI discontinuation or dose reduction. When symptoms emerge in this context, clinicians should be encouraged to include the discontinuation syndrome on their list of differential diagnoses. Awareness of some of the more unusual symptoms, such as dizziness and shock-like sensations, and re-education of patients prior to stopping or tapering an SSRI, should prevent unnecessary and expensive medical investigations.

What is the mechanism behind this problem?

The biological mechanisms underlying this syndrome are not well understood, although an acute decrease in synaptic serotonin in the face of down-regulated or desensitized serotonin receptors has been postulated.

Who is at risk?

The SSRI discontinuation syndrome does not appear to discriminate based on age, sex, diagnosis or dose of SSRI (both low and high doses have been reported). As I mentioned, there appears to be less risk with the abrupt interruption of fluoxetine. Paroxetine is the SSRI most often mentioned in the case reports and the reason for this may be as simple as the fact that it is most frequently prescribed. An alternative explanation may involve paroxetine s affinity for cholinergic (muscarinic) receptors, causing cholinergic rebound on discontinuation. However, this explanation wouldn’ t account for the full spectrum of symptoms described.

Can it be avoided or treated?

Review of the SSRI discontinuation literature suggests that symptoms may occur even if the SSRI dose is tapered gradually. In half of 50 reported cases, an attempt was made to taper the SSRI, although details concerning the duration and rapidity of taper were not provided consistently. At this point, it is unclear whether tapering SSRIs will reduce the risk nor is it clear whether we should advocate the routine taper of SSRIs when stopping treatment. The only known effective treatment is the re-introduction of the SSRI which is associated with rapid resolution of symptoms. Unfortunately, the syndrome tends to recur in approximately 75% of patients when the same SSRI is later discontinued.

Source: http://www.circlemedhealthcare.com/ssri.pdf

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Antipsychotics

What are antipsychotics used for?

Antipsychotics are usually used to help treat people with schizophrenia and similar conditions such as psychosis. They are also used to treat other problems such as mania, hypomania and mood disorders. Occasionally antipsychotics are used to help manage agitation or anxiety. Medicines are often used to treat more than one condition, so if you are not sure why you have been prescribed an antipsychotic, you should discuss this with your doctor.

Antipsychotics are classified into two groups, ‘typical’ or ‘first-generation’ antipsychotics and ‘atypical’ or ‘second generation’ antipsychotics. Examples of ‘typical antipsychotics’ include, haloperidol, chlorpromazine and flupentixol. Examples of ‘atypical antipsychotics’ include risperidone, olanzapine, clozapine and aripiprazole. The difference between the two groups includes the type and frequency of the side effects that they may cause.

What are the benefits of taking antipsychotics?

People with schizophrenia or psychosis may have a range of symptoms that are often thought of in two groups – ‘positive’ and ‘negative’ symptoms. Positive symptoms include hallucinations and delusions, which can include symptoms such as hearing voices, or experiencing ‘strange things’ such as seeing or feeling things that may not be real or having mistaken beliefs. People may also feel suspicious or paranoid, or feel that other people can read their thoughts. Negative symptoms are less noticeable than positive symptoms, and include tiredness, lack of concentration and lack of energy. People may become quite inactive and withdrawn from normal everyday activities.

Antipsychotics can help to treat some of these symptoms and keep them under control in the long term. Treating these symptoms should help people feel less confused, anxious and restless, and help them to think more clearly. This will help them to cope better with the stresses of everyday life, and help them to return to normal activities such as work or hobbies. Antipsychotics may also help people engage better with other kinds of therapies such as psychological treatments and therefore allow for a better response.

How quickly do antipsychotics work?

Antipsychotics work over a period of weeks. People may find that they feel calmer soon after starting treatment, but it may take several weeks until they have their full effect. Not everybody benefits from antipsychotics but most people do. If you do not feel any benefit or improvement in your symptoms after six to eight weeks, you should discuss this with your doctor or healthcare worker.

What are the usual doses of antipsychotics and how should I take them?

People will usually be started on a low dose, which will then slowly be increased to the usual effective dosage range for that medicine. Refer to the manufacturer’s patient information leaflet for the antipsychotic that you have been given. Do not change your dose of medication without checking with your doctor, as it can affect your response to the medication, or may be harmful.

What should I do if I miss a dose?

You will get the most out of your medication when taken correctly and regularly. If you miss, or forget a dose at your usual time, but remember within an hour or two take it straight away. If it is longer than this just leave out the missed dose and take the next dose at the usual time. Never take extra medication at the next dose. If you find it difficult to remember taking medication speak to your pharmacist or healthcare worker.

For how long should I take antipsychotics?

Your doctor will discuss with you how long you will need to take medication for, which will vary depending on the type of illness you have. Some people may need to take medication for a number of years and others need to stay on medication longer. Taking medication regularly may prevent you from becoming unwell. Your doctor should regularly review your medication to check whether you are experiencing any unwanted effects and make sure that your dose is still right for you. Stopping antipsychotics suddenly may cause ‘discontinuation symptoms’ such as jerky movements and nausea. Your original symptoms may also return after three to six months of stopping. The dose should usually be reduced gradually before stopping. Check with your doctor for advice about this. Antipsychotics are not addictive.

What are the side effects of antipsychotics?

As with all medicines there is a risk of unwanted effects (side effects). Some can occur soon after starting treatment so you may experience these before you feel better. Most are temporary and should go away after a few days or weeks. Not everyone will get side effects and people experience them to different degrees. If you feel that you have side effects that are causing you discomfort, discuss this with your doctor, pharmacist, nurse or healthcare worker. The table on the following page lists some of the main recognised side effects of antipsychotics but these will depend on the individual antipsychotic you are taking.

What about alcohol and ‘street’ drugs?

Both alcohol and antipsychotics can affect the brain so it is not recommended that you drink alcohol while taking antipsychotics. Drinking alcohol can make psychosis worse and in combination with antipsychotics can cause severe drowsiness. Once you are used to the medication and know the effects of taking alcohol you may be able to drink alcohol occasionally and in small amounts. It is good to be cautious because alcohol affects people in different ways, especially when taking medication.

Do not stop taking your medication because you feel like drinking alcohol. If you drink alcohol, drink only small amounts. Never drink alcohol and drive while taking medication.

‘Street’ drugs (for example, cannabis, ecstasy, speed, heroin and cocaine) can often also make psychosis worse. People taking ecstasy whilst on antipsychotics are more likely to experience movement disorders. There is very little information on taking antipsychotics with other ‘street’ drugs, so the effect and safety of doing this is unknown. It is best if you do not take ‘street’ drugs whilst taking antipsychotics. You may need to get advice and support to help you do this.

What about other medicines?

If you take any other medicines or herbal remedies including any that have been newly prescribed or bought, it is important to check with your doctor or pharmacist that they are safe with antipsychotics. You must take particular care when taking drugs that lower your blood pressure with antipsychotics.

When should I be cautious?

It is usually safe to take antipsychotics regularly, as prescribed by your doctor, but they are not suitable for everyone. If any of the following situations apply to you, you should tell your doctor immediately.

1 If you are allergic to antipsychotics (if you have taken it before and developed a rash, itching, swollen mouth or throat);

2 If you have diabetes, epilepsy (or have had a fit in the past), suffer from kidney disease, heart problems or have had a stroke;

3 If you have Parkinson’s disease or take any medicines usually used to treat this;

4 If you have an abnormal heart rate or take medicines to control your heart rate;

5 If you have ever had a history of breast cancer or a prolactin dependent tumour;

6 If you have phaeochromocytoma (a tumour of the adrenal gland);

7 If you are pregnant, or are planning to become pregnant; or

8 If you are breastfeeding.

Please refer to the manufacturer’s patient information leaflet that comes with your medicine for more information and the full list of side effects and precautions. If you have any questions or concerns about your medicines, or if you are worried about anything you think might be a side effect, ask your doctor, pharmacist or nurse.

This leaflet gives you some information about this medicine. It does not replace the expertise or judgement of a doctor, pharmacist or other healthcare professional. It is not a manufacturer’s patient information leaflet and is not to be taken as a substitute for, or an endorsement of, the manufacturer’s information or advice in respect of any medicine referred to in this leaflet. You might find more information in other leaflets or books, or on the internet but remember, the internet is not always accurate.

Whilst every care has been taken in the compilation of this leaflet, CNWL is not responsible for any loss or damage howsoever caused as a result of any inaccuracy or error contained in this leaflet, including (for the avoidance of doubt) in relation to breach of contract, misrepresentation or negligence whether of CNWL or any other person; but nothing in this leaflet shall exclude or restrict liability for death or personal injury resulting from negligence.

The information given in this leaflet is current as at the publication date.

This leaflet has been written by Central and North West London Mental Health NHS Trust Pharmacy Department, 30 Eastbourne Terrace, London W2 6LA www.cnwl.org – Publication Date: May 2007

Source: http://beh.zedcore.com

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