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Original Articles

Comparison of Risperidone and Placebo for Psychosis and Behavioral Disturbances Associated With Dementia: A Randomized, Double-Blind Trial

Ira R. Katz, Dilip V. Jeste, Jacobo E. Mintzer, Christopher Clyde, Judy Napolitano, and Martin Brecher for the Risperidone Study Group

Published: February 28, 1999

Article Abstract

Background: We report the findings from the first large, double-blind, placebo-controlled study conducted to evaluate the efficacy and safety of risperidone in the treatment of psychotic and behavioral symptoms in institutionalized elderly patients with dementia.

Method: 625 patients (67.8% women; mean age = 82.7 years) with DSM-IV diagnoses of Alzheimer’s disease (73%), vascular dementia (15%), or mixed dementia (12%) and significant psychotic and behavioral symptoms were included. Each patient was randomly assigned to receive placebo or 0.5 mg/day, 1 mg/day, or 2 mg/day of risperidone for 12 weeks. The primary outcome measure was the Behavioral Pathology in Alzheimer’s Disease rating scale (BEHAVE-AD).

Results: The study was completed by 70% of the patients. Baseline Functional Assessment Staging scores were 6 or 7 in more than 95% of the patients, indicating severe dementia. At endpoint, significantly greater reductions in BEHAVE-AD total scores and psychosis and aggressiveness subscale scores were seen in patients receiving 1 and 2 mg/day of risperidone than in placebo patients (p = .005 and p < .001, respectively). At week 12, 0.5 mg/day of risperidone was superior to placebo in reducing BEHAVE-AD aggression scores (p = .02). More adverse events were reported by patients receiving 2 mg/day of risperidone than 1 mg/day. The most common dose-related adverse events were extrapyramidal symptoms, somnolence, and mild peripheral edema. The frequency of extrapyramidal symptoms in patients receiving 1 mg/day of risperidone was not significantly greater than in placebo patients.

Conclusion: Risperidone significantly improved symptoms of psychosis and aggressive behavior in patients with severe dementia. Results show that 1 mg/day of risperidone is an appropriate dose for most elderly patients with dementia.

Volume: 60

Quick Links: Dementia , Neurologic and Neurocognitive

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Letter to the Editor

Stigma Kills Psychiatric Patients and Is Now Killing Clinical Research Too

Robert M. Post, MD, argues that NIMH should abandon the RDoC framework and restore funding for clinical...

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