A long-term, multicenter, open-label study of risperidone in elderly patients with psychosis. On behalf of the Risperidone Working Group

Int J Geriatr Psychiatry. 2000 Jun;15(6):506-14. doi: 10.1002/1099-1166(200006)15:6<506::aid-gps146>3.0.co;2-v.


Rationale: Studies have shown that risperidone is safe and efficacious in young and middle-aged adults with chronic schizophrenia, but considerably fewer data are available on the treatment of elderly patients with schizophrenia 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 patients (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 (> or =20% reduction in Positive 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 severity of illness scores showed continued improvement through month 12 (p<0.001). In contrast, PANSS data from a historical comparable control group of patients receiving conventional antipsychotic agents showed no symptom improvement over a 12-month treatment period. The severity of preexisting extrapyramidal symptoms (EPS) in patients treated with risperidone decreased significantly from baseline to endpoint (p<0.001), and the use of antiparkinsonian 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 antipsychotic agents for 1 year.

Conclusions: Long-term treatment with risperidone was associated with continued symptom improvement, a decrease in the severity of preexising EPS, and a low incidence of TD in elderly psychotic patients.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / therapeutic use*
  • Chronic Disease
  • Delusions / diagnosis
  • Delusions / drug therapy*
  • Delusions / psychology
  • Dyskinesia, Drug-Induced / diagnosis
  • Dyskinesia, Drug-Induced / etiology
  • Female
  • Humans
  • Long-Term Care
  • Male
  • Middle Aged
  • Psychiatric Status Rating Scales
  • Psychotic Disorders / diagnosis
  • Psychotic Disorders / drug therapy*
  • Psychotic Disorders / psychology
  • Risperidone / adverse effects
  • Risperidone / therapeutic use*
  • Schizophrenia / diagnosis
  • Schizophrenia / drug therapy*
  • Schizophrenic Psychology
  • Treatment Outcome


  • Antipsychotic Agents
  • Risperidone