European Commission Approves XEPLION® for Treatment of Schizophrenia

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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A. Characteristic symptoms: Two (or more) of the following, each present for a significant portion of time during a 1-month period (or less if successfully treated):

(1) delusions

(2) hallucinations

(3) disorganized speech (e.g., frequent derailment or incoherence)

(4) grossly disorganized or catatonic behavior

(5) negative symptoms, i.e., affective flattening, alogia, or avolition

Note: Only one Criterion A symptom is required if delusions are bizarre or hallucinations consist of a voice keeping up a running commentary on the person’s behavior or thoughts, or two or more voices conversing with each other.

B. Social/occupational dysfunction: For a significant portion of the time since the onset of the disturbance, one or more major areas of functioning such as work, interpersonal relations, or self-care are markedly below the level achieved prior to the onset (or when the onset is in childhood or adolescence, failure to achieve expected level of interpersonal, academic, or occupational achievement).

C. Duration: Continuous signs of the disturbance persist for at least 6 months. This 6-month period must include at least 1 month of symptoms (or less if successfully treated) that meet Criterion A (i.e., active-phase symptoms) and may include periods of prodromal or residual symptoms. During these prodromal or residual periods, the signs of the disturbance may be manifested by only negative symptoms or two or more symptoms listed in Criterion A present in an attenuated form (e.g., odd beliefs, unusual perceptual experiences).

D. Schizoaffective and Mood Disorder exclusion: Schizoaffective Disorder and Mood Disorder With Psychotic Features have been ruled out because either (1) no Major Depressive, Manic, or Mixed Episodes have occurred concurrently with the activephase symptoms; or (2) if mood episodes have occurred during active-phase symptoms, their total duration has been brief relative to the duration of the active and residual periods.

E. Substance/general medical condition exclusion: The disturbance is not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition.

F. Relationship to a Pervasive Developmental Disorder: If there is a history of Autistic Disorder or another Pervasive Developmental Disorder, the additional diagnosis of Schizophrenia is made only if prominent delusions or hallucinations are also present for at least a month (or less if successfully treated).

Schizophrenia Subtypes

The subtypes of Schizophrenia are defined by the predominant symptomatology at the time of evaluation.

295.30 Paranoid Type

A type of Schizophrenia in which the following criteria are met:

A. Preoccupation with one or more delusions or frequent auditory hallucinations.

B. None of the following is prominent: disorganized speech, disorganized or catatonic behavior, or flat or inappropriate affect.

295.10 Disorganized Type

A type of Schizophrenia in which the following criteria are met:

A. All of the following are prominent:

(1) disorganized speech

(2) disorganized behavior

(3) flat or inappropriate affect

B. The criteria are not met for Catatonic Type.

295.20 Catatonic Type

A type of Schizophrenia in which the clinical picture is dominated by at least two of the following:

(1) motoric immobility as evidenced by catalepsy (including waxy flexibility) or stupor

(2) excessive motor activity (that is apparently purposeless and not influenced by external stimuli)

(3) extreme negativism (an apparently motiveless resistance to all instructions or maintenance of a rigid posture against attempts to be moved) or mutism

(4) peculiarities of voluntary movement as evidenced by posturing (voluntary assumption of inappropriate or bizarre postures), stereotyped movements, prominent mannerisms, or prominent grimacing

(5) echolalia or echopraxia

295.90 Undifferentiated Type

A type of Schizophrenia in which symptoms that meet Criterion A are present, but the criteria are not met for the Paranoid, Disorganized, or Catatonic Type.

295.60 Residual Type

A type of Schizophrenia in which the following criteria are met:

A. Absence of prominent delusions, hallucinations, disorganized speech, and grossly disorganized or catatonic behavior.

B. There is continuing evidence of the disturbance, as indicated by the presence of negative symptoms or two or more symptoms listed in Criterion A for Schizophrenia, present in an attenuated form (e.g., odd beliefs, unusual perceptual experiences).

Classification of Longitudinal Course for Schizophrenia

These specifiers can be applied only after at least 1 year has elapsed since the initial onset of active-phase symptoms:

Episodic With Interepisode Residual Symptoms. This specifier applies when the course is characterized by episodes in which Criterion A for Schizophrenia is met and there are clinically significant residual symptoms betweenthe episodes. With Prominent Negative Symptoms can be added if prominent negative symptoms are present during these residual periods.

Episodic With No Interepisode Residual Symptoms.

This specifier applies when the course is characterized by episodes in which Criterion A for Schizophrenia is met and there are no clinically significant residual symptoms between the episodes.

Continuous. This specifier applies when characteristic symptoms of Criterion A are met throughout all (or most) of the course. With Prominent Negative Symptoms can be added if prominent negative symptoms are also present.

Single Episode In Partial Remission. This specifier applies when there has been a single episode in which Criterion A for Schizophrenia is met and some clinically significant residual symptoms remain. With Prominent Negative Symptoms can be added if these residual symptoms include prominent negative symptoms.

Single Episode In Full Remission. This specifier applies when there has been a single episode in which Criterion A for Schizophrenia has been met and no clinically significant residual symptoms remain.

Other or Unspecified Pattern. This specifier is used if another or an unspecified course pattern has been present.

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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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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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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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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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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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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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This booklet does not provide information about diagnosing mental disorders. Choosing the right medication, medication dose, and treatment plan should be based on a person’s individual needs and medical situation, and under a doctor’s care.

Information about medications is frequently updated. Check the FDA Web site for the latest information on warnings, patient medication guides, or newly approved medications. Throughout this document you will see two names for medications—the generic name and in parenthesis, the trade name. An example is fluoxetine (Prozac). See the end of this document for a complete alphabetical listing of medications.

What are psychiatric medications?

Psychiatric medications treat mental disorders. Sometimes called psychotropic or psychotherapeutic medications, they have changed the lives of people with mental disorders for the better. Many people with mental disorders live fulfilling lives with the help of these medications. Without them, people with mental disorders might suffer serious and disabling symptoms.

How are medications used to treat mental disorders?

Medications treat the symptoms of mental disorders. They cannot cure the disorder, but they make people feel better so they can function.

Medications work differently for different people. Some people get great results from medications and only need them for a short time. For example, a person with depression may feel much better after taking a medication for a few months, and may never need it again. People with disorders like schizophrenia or bipolar disorder, or people who have long-term or severe depression or anxiety may need to take medication for a much longer time.

Some people get side effects from medications and other people don’t. Doses can be small or large, depending on the medication and the person. Factors that can affect how medications work in people include:
Type of mental disorder, such as depression, anxiety, bipolar disorder, and schizophrenia
Age, sex, and body size
Physical illnesses
Habits like smoking and drinking
Liver and kidney function
Genetics
Other medications and herbal/vitamin supplements
Diet
Whether medications are taken as prescribed.

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

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ZYPREXA is a brand name for a prescription medicine that is approved by the FDA for treating the symptoms of schizophrenia, acute mixed or manic episodes of bipolar I disorder and for maintenance treatment in bipolar disorder.

Important Safety Information

Facts About ZYPREXA
ZYPREXA has been prescribed to nearly 24 million people in 84 countries since its approval in 1996

ZYPREXA was the first of a newer generation of antipsychotic medications (called atypical antipsychotics) approved for the long-term treatment of schizophrenia

ZYPREXA was the first atypical antipsychotic approved for the treatment of acute bipolar mania

ZYPREXA has benefits in controlling positive symptoms (hallucinations, delusions) and negative symptoms (apathy, social withdrawal) of schizophrenia

ZYPREXA is easy to use — it can be taken once a day, with or without food

How ZYPREXA® (olanzapine) Works

ZYPREXA is a kind of medication known as an atypical antipsychotic. It belongs to a larger category of medications that affect the mind, called psychotropics. Antipsychotic medicines are psychotropic medications that treat the symptoms of psychotic disorders, such as schizophrenia. They may also be prescribed to treat acute mixed or manic episodes of bipolar disorder.
Antipsychotic Medicines

Antipsychotic medicines are believed to work by balancing the chemicals naturally found in the brain.

Antipsychotic medicines can be used to treat the symptoms of psychosis in schizophrenia, such as hallucinations and delusions, and may improve symptoms, such as fears and voices.

Antipsychotic medicines are also prescribed to treat acute mixed or manic episodes of bipolar disorder. They may improve such symptoms as sleep disturbances, irritability, racing thoughts, and anxiety. Some antipsychotic medications are also prescribed to help control ongoing symptoms.

When you start taking ZYPREXA, keep in mind that it can take several weeks before you notice a difference in the way you feel. The time it takes to experience the full effects of ZYPREXA may vary from person to person, depending on individual symptoms and the dosage prescribed.

It is important to take ZYPREXA the way your doctor has recommended — the right dose, at the same time, every day.

Managing Side Effects

Like any medicine, ZYPREXA may have some side effects. Medicines affect people in different ways. You may experience some of the side effects listed here.
The most common side effects of ZYPREXA are:
Drowsiness
Feeling more hungry than usual
Gaining weight
Dizziness
Dry mouth
Constipation
Upset stomach
Feeling weak
Restlessness
Tremors (shakes)

These side effects generally do not bother people enough to cause them to stop taking ZYPREXA. This is not a complete list of possible side effects. For a more complete list, read the important safety information. If you have questions, be sure to ask your doctor for more information. If you think you may be experiencing side effects, talk with your healthcare provider.

Dosing

Schizophrenia
Usual Dose — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Bipolar Disorder
Usual Monotherapy Dose — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (eg, nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine. When indicated, dose escalation should be performed with caution in these patients.

Getting the Most From ZYPREXA® (olanzapine)

Unlike aspirin for a headache or medicine to relieve a cough, you probably can’t feel how ZYPREXA is helping relieve your symptoms. Keep in mind that it can take several weeks before you notice a difference in the way you feel. The time it takes to experience the full effects of ZYPREXA may vary from person to person, depending on individual symptoms and the dosage prescribed.
Create a Routine

It is important to take ZYPREXA the way your doctor has recommended — the right dose, at the same time, every day. Here are a few ways you can help yourself take ZYPREXA properly every day:
Take your medicine on a schedule that’s linked with certain activities you do every day (such as brushing your teeth, taking your vitamins, or eating breakfast or dinner. Or, set your medicine on the nightstand next to your bed or next to your favorite mug on the kitchen counter)

Organize your pills in a pill counter to keep track of the doses you’ve taken

Use a calendar to keep track of the doses you’ve taken

Ask your doctor if your medicine schedule can be changed so that you take fewer doses each day

Source: http://www.zyprexa.com/about_zyprexa.jsp

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Antipsychotics can be classified by their structure but can also be distinguished by their pharmacology, their action at receptors, and by their clinical properties. Typical (also called conventional) antipsychotics act primarily at dopamine receptors. Atypical antipsychotics act on other receptors as well as dopamine, and are less likely than typical antipsychotics to cause movement disorders as a side effect. The following are atypical antipsychotics are licensed in the UK: amisulpiride (brand name Solian), aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and zotepine (Zoleptil).

As with all effective medicines antipsychotics can produce side effect in some individuals. The most common side effects include movement disorders that may resemble Parkinson’s disease (referred to as extrapyramidal effects, anticholinergic effects such as dry mouth, feelings of dizziness or light headedness, constipation and blurred vision (so called as they are due to the action of these drugs on cholinergic receptors in the brain and body) and weight gain.

It is important to appreciate that this is not a comprehensive list of the possible side effects of antipsychotics. Full guidance on prescribing and use, including possible side effects, of antipsychotics is provided in the Summary of Product Characteristics (SPC) for health professionals and the patient information leaflet (PIL) that should accompany the medicine.

More recently concerns have arisen that patients receiving risperidone and olanzapine in dementia were at an increased risk of stroke compared with patients receiving placebo (dummy pill) and that the balance of risks and benefits was considered to be unfavourable in the dementia population. Atypical antipsychotics are not authorised for the treatment of dementia related psychosis and/or behaviour disturbances. Prescribers were informed of this risk and advised to review the treatment of all patients receiving atypical antipsychotics in dementia as the risk of stroke for other atypical antipsychotics could not be excluded:
Source: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Antipsychoticdrugs/index.htm

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