Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder

Exclusion Criteria

• •Patients are included in the National Non-Rechallenge Master File for Clozaril.
• •Patients have a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine or FazaClo.
• •Patients have a history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
• •Patients have a total white blood cell (WBC) count below 4000/mm3 or an absolute neutrophil count (ANC) below 2000/mm3.
• •Patients have a history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
• •Patients have a known history of human immunodeficiency virus infection.
• •Patients have a history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
• •Patients are unable to communicate with the investigator.
• •Patients have a history of allergic reactions to clozapine or chemically related psychotropic drugs.
• •Patients have a concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-IV criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinson's disease.
• •Patients have had electroconvulsive therapy within the past three months.
• •Patients have demonstrated clinically significant homicidal behavior within the past 12 months.
• •Patients have received an investigational drug within the past 30 days.
• •Patients have a history of narrow-angle glaucoma.
• •Patients require treatment with drugs that are known to interact with clozapine (e.g., agents having a well-known potential to suppress bone-marrow functioning, drugs that are highly protein-bound, cimetidine, or phenytoin). Clozapine may also potentiate the effects of antihypertensives and anticholinergics; therefore, caution should be taken if patients receiving these drugs are enrolled in the study.
• •Patients are morbidly obese (defined as having a body mass index \[BMI\] greater than 40; BMI = weight \[kg\]/height \[m2\]).
• •Patients have a known history of phenylketonuria. FazaClo contains aspartame, a source of phenylalanine which can be harmful to patients with phenylketonuria.