Branded versus Generic Clozapine for Treatment of Schizophrenia

• DOI: 10.1345/aph.1c069
• Publication Date: 2003-06-04T20:31:57Z
• Authors: Eugene H Makela; William D Cutlip; James M Stevenson; Jason M Weimer; Ehab S Abdallah; Raja S Akhtar; Ahmed S Aboraya; Erdogan Gunel
• Keywords: Adult; Male; Psychiatric Status Rating Scales; Adolescent; Dose-Response Relationship, Drug; Middle Aged; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Therapeutic Equivalency; Area Under Curve; Schizophrenia; Humans; Female; Clozapine; Antipsychotic Agents

OBJECTIVE: To report clinical findings resulting from a switch branded to generic clozapine. METHODS: Twenty patients diagnosed with schizophrenia were followed in this naturalistic outpatient study. The Positive and Negative Syndrome Scale (PANSS), Beck Anxiety Inventory (BAI), Abnormal Involuntary Movement Scale, the Disorder Assessment used assess differences status of before after switching Clozaril clozapine (Mylan Pharmaceuticals). Results analyzed by means paired t-test calculation percent change mean scores. A clinically significant as measured PANSS was defined ± 20% scores at final evaluation. design open-label non-blinded. RESULTS: At evaluation, revealed no between for total PA NSS, positive symptom, negative general psychopathology subscales PANSS, BAI. There changes any measure. CONCLUSIONS: In small group schizophrenia, deterioration several domains noted changing This finding is consistent pharmacologic data suggesting bioequivalence 2 products. Results, however, must be interpreted cautiously due lack optimal study controls sample size.