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Clozaril

Clozapine (sold as Clozaril®, Leponex®, Fazaclo®) was the first of the atypical antipsychotics to be developed. It was approved by the United States FDA in 1989 and is the only FDA-approved medication indicated for treatment-resistant schizophrenia and for reducing the risk of suicidal behaviour in patients with schizophrenia. more...

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History and main uses

Clozapine was developed by Sandoz in 1961, and introduced in Europe ten years later. In 1975, after reports of agranulocytosis leading to death in some clozapine-treated patients, Clozapine was voluntarily withdrawn by the manufacturer. Clozapine fell out of favor for more than a decade. However, when studies demonstrated that clozapine was more effective against treatment-resistant schizophrenia than other antipsychotics, the FDA and health authorities in most other countries approved its use only for treatment-resistant schizophrenia, and required regular haematological monitoring to detect granulocytopenia, before agranulocytosis develops. In December of 2002, Clozapine was also approved for reducing the risk of suicide in schizophrenic or schizoaffective patients judged to be at chronic risk for suicidal behavior.

Commonly approved indications

Treatment-resistant schizophrenia, if the required hematologic monitoring is adhered to
Reducing the risk of suicide in schizophrenic or schizoaffective patients judged to belong to a high risk group with chronic risk for suicidal behavior. Clozapine was shown to prolong the time to suicidal attempt significantly greater than Olanzapine (Zyprexa®).

Clozapine works equally well against positive (e.g. delusions, hallucinations) and negative (e.g. emotional and social withdrawal) symptoms of schizophrenia. It has no dyscognitive effect often seen with other psychoactive drugs and is even able to increase the capabilities of the patient to react to this environment and thereby fosters social rehabilitation.

Off-label and investigational drug use

Treatment of psychosis in L-Dopa treated patients (25 to 50 mg at bedtime is often sufficient); this indication is currently approved in Switzerland
Treatment of otherwise resistant acute episodes of mania
Treatment of psychotic symptoms occurring in patients with dementia of the Levy-body-type
Treatment of severe cases of obsessive compulsive disorder
Treatment of intractable chronic insomnia, if all other measurements have failed

Though much research has been done evaluating the benefit of clozapine in treating the aforementioned conditions, it is too early to come to a conclusive result. If you contemplate clozapine as drug for these conditions, weigh carefully benefits and risks and inform the patients fully, if possible, about the advantages and risks of clozapine treatment, before a joint decision is made. If the patient is not able to make own decisions, parents or guardians or the competent court must give their consent.

Chemistry

Clozapine is yellow crystalline solid with melting point 183-184 °C. It is insoluble in water, soluble in acetone, very well soluble in chloroform. Chemical name is <8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzodiazepine>.

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Antipsychotic use and cardiac events
From American Family Physician, 11/15/05 by Karl E. Miller

Patients treated with some antipsychotic medications have been shown to be at increased risk for ventricular arrhythmias, cardiac arrest, and sudden death. This includes patients with schizophrenia who are treated with thioridazine (Mellaril), haloperidol (Haldol), and other conventional antipsychotics (see accompanying table). This increased risk has been attributed to the QT-prolonging properties of conventional antipsychotics. The newer atypical antipsychotics may be more effective in the treatment of negative symptoms in schizophrenia, and they may have a lower risk of extrapyramidal side effects and tardive dyskinesia compared with conventional antipsychotics. Because of this improved side effect profile, the use of atypical antipsychotics has increased. The effects of atypical antipsychotics on cardiac events and sudden death has not been established. Liperoti and associates performed a case-control study to compare the effects of conventional and atypical antipsychotics on the risk of hospitalization for ventricular arrhythmias or cardiac arrest among older patients.

The authors collected data from the Systematic Assessment of Geriatric Drug Use via Epidemiology database for patients at Medicaid- and Medicare-certified nursing homes in six states. This information is linked to the Medicare inpatient claim files. Patients were included in the study if they had a primary diagnosis of cardiac arrest or ventricular arrhythmia. A control group consisting of residents in the same facilities was selected from the database.

A total of 649 patients had used antipsychotic medication within seven days of admission, and 2,962 patients were included in the control group. The use of conventional antipsychotics was associated with an increased risk of hospitalizations for cardiac arrest or ventricular arrhythmias (odds ratio [OR], 1.86; 95% confidence interval [CI], 1.27 to 2.74). The use of atypical antipsychotics was not associated with an increased risk for hospitalization. Patients with cardiac disease who took conventional antipsychotics were at increased risk of hospitalizations for ventricular arrhythmias compared with the control group (OR, 3.27; 95% CI, 1.95 to 5.47). The synergy index for this data was 1.19, indicating that there was no interaction between conventional antipsychotic use and preexisting cardiac disease.

The authors conclude that the use of conventional antipsychotic medications is associated with an increased risk of hospitalizations for cardiac arrest and ventricular arrhythmias, and that atypical antipsychotics are not associated with increased risk. They add that the use of conventional antipsychotics should be avoided, if possible, in patients with cardiac disease.

KARL E. MILLER, M.D. Liperoti R, et al. Conventional and atypical antipsychotics and the risk of hospitalization for ventricular arrhythmias or cardiac arrest. Arch Intern Med March 28, 2005;165:696-701.

Antipsychotic Medications

Atypical

Clozapine (Clozaril) Olanzapine (Zyprexa) Quetiapine (Seroquel) Risperidone (Risperdal)

Conventional

Chlorpromazine (Thorazine) Chlorprothixene (Taractan) Fluphenazine (Prolixin) Haloperidol (Haldol) Loxapine (Loxitane) Molindone (Moban) Perphenazine (Trilafon) Promazine * Thioridazine (Mellaril) Thiothixene (Navane) Trifluoperazine (Stelazine)

*--Not available in the United States.

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