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International Multisite Double-Blind Trial of the Atypical Antipsychotics Risperidone and Olanzapine in 175 Elderly Patients With Chronic Schizophrenia

Received March 10, 2003; revised July 7, 2003; accepted July 8, 2003. From the University of California, San Diego (DVJ), the VA San Diego Healthcare System (DVJ), the Abarbanel Mental Health Center, Bat-Yam, Israel (YB), St. John's Episcopal Hospital, South Shore, Far Rockaway, NY (SM), Johnson & Johnson Pharmaceutical Research and Development, Titusville, NJ (FG) and Janssen Products, Inc. (GG). Address correspondence to: Dilip V. Jeste, M.D., Estelle and Edgar Levi Chair in Aging Professor of Psychiatry and Neurosciences, University of California, San Diego, VA San Diego Healthcare System (116A-1), 3350 La Jolla Village Dr., San Diego, CA 92161. e-mail: djeste{at}ucsd.edu

Objective: The authors compared the effects of the two most commonly used atypical antipsychotics, risperidone and olanzapine, in elderly patients with schizophrenia. Methods: In an 8-week, international, double-blind study, patients (outpatients, hospital inpatients, and residents of nursing or boarding homes) were randomly assigned to receive risperidone (1 mg to 3 mg/day) or olanzapine (5 mg to 20 mg/day). The main outcome measures were changes in Positive and Negative Syndrome Scale (PANSS) total scores and rates of extrapyramidal symptoms (EPS). Results: Subjects were 175 patients age 60 years or over with schizophrenia or schizoaffective disorder. The mean duration of illness was 36.5 years. Median doses were 2 mg/day of risperidone and 10 mg/day of olanzapine. PANSS total scores and four of the five PANSS factor scores (positive symptoms, negative symptoms, disorganized thoughts, and anxiety/depression) improved significantly at all time-points and at endpoint in both groups; between-treatment differences were not significant. EPS-related adverse events were reported by 9.2% of patients in the risperidone group and 15.9% in the olanzapine group; the between-treatment difference was not significant. Total scores on the Extrapyramidal Symptom Rating Scale were reduced in both groups at endpoint; between-treatment differences were not significant. Clinically relevant weight gain was seen in both groups, but was significantly less frequent in risperidone patients than in olanzapine patients. Conclusions: Stable elderly patients with chronic schizophrenia receiving appropriate doses of risperidone or olanzapine over an 8-week period experienced significant reductions in the severity of psychotic and extrapyramidal symptoms, with a relatively low risk of side effects.

Key Words: Risperidone • Olanzapine • Atypical Antipsychotics • Schizophrenia