A long-term, multicenter, open-label study of risperidone in elderly patients with psychosis

Rationale. Studies have shown that risperidone is safe and efficacious in y oung and middle-aged adults with chronic schizophrenia, but considerably fe wer data are availabale on the treatment of elderly patients with schizophr enia or other psychotic disorders, particularly long-term outcomes. Objective. A 12-month, open-label study was conducted to assess the effects of risperidone in elderly, chronically ill, psychotic patients. Methods. This study enrolled 180 elderly, chronically ill, psychotic patien ts (median age, 72 years [range 54-89]), 97 of whom completed the 12-month study. At endpoint, the mean dose of risperidone was 3.7 mg/day. Results. Clinical improvement (greater than or equal to 20% reduction in Po sitive and Negative Syndrome Score [PANSS] total score) was achieved by 54% of patients at endpoint. There were significant reductions in PANSS total, subscale (positive, negative, and general psychopathology), and cognition cluster scores at endpoint (p < 0.001). Clinical Global Impressions severit y of illness scores showed continued improvement through month 12 (p < 0.00 1). In contrast, PANSS data from a historical comparable control group of p atients receiving conventional antipsychotic agents showed no symptom impro vement over a 12-month treatment period. The severity of preexisting extrap yramidal symptoms (EPS) in patients treated with risperidone decreased sign ificantly from baseline to endpoint (p < 0.001), and the use of antiparkins onian medication decreased from 41.1% of patients before the trial to 25.6% during the trial. There were no spontaneous reports of tardive dyskinesia (TD) and the incidence of assessed TD was 4.3% in contrast to the expected 26% reported in middle-aged and elderly patients receiving conventional ant ipsychotic agents for 1 year. Conclusions. Long-term treatment with risperidone was associated with conti nued symptom improvement, a decrease in the severity of preexising EPS, and a low incidence of TD in elderly psychotic patients. Copyright (C) 2000 Jo hn Wiley & Sons, Ltd.