ICI-204,636, A NOVEL, ATYPICAL ANTIPSYCHOTIC - EARLY INDICATION OF SAFETY AND EFFICACY IN PATIENTS WITH CHRONIC AND SUBCHRONIC SCHIZOPHRENIA

We evaluated the effects of ICI 204,636 in 12 hospitalized patients wi th schizophrenia in a double-blind, placebo-controlled, parallel-group , rising-dose study. Patients met the Diagnostic and Statistical Manua l of Mental Disorders, Third Edition, Revised criteria for chronic or subchronic schizophrenia and had a total score greater than or equal t o 30 on the 18-item Brief Psychiatric Rating Scale (BPRS) and a score greater than or equal to 3 on the Clinical Global Impression (CGI) Sev erity of Illness item. Patients received 21 days of double-blind treat ment with increasing doses of ICI 204,636 (25 to 250 mg/d) or placebo. Efficacy was assessed using the BPRS and CGI. Response to treatment w as defined as a greater than or equal to 30% decrease in the BPRS tota l score from baseline. Extrapyramidal symptoms and abnormal involuntar y movements were assessed using the Simpson Scale and Abnormal Involun tary Movement Scale.