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Regular Article |
Received July 28, 2002; revised January 18, 2003; accepted February 11, 2003. From the University of Southern California, Keck School of Medicine, Department of Psychiatry, Los Angeles CA (LS), the University of Pennsylvania, Department of Psychiatry, Mental Illness Research, Education, and Clinical Center, Philadelphia Veterans Affairs Medical Center, Philadelphia, PA (IRK), the University of Southern California Keck School of Medicine, Department of Preventive Medicine, Los Angeles CA (SP,SPA), and the Janssen Research Foundation, Titusville NJ (JN,RM). Address correspondence to Stanley Azen, Ph.D., Department of Preventive Medicine, Keck School of Medicine, University of Southern California, 1540 Alcazar St., CHP-218, Los Angeles CA 90033. e-mail: sazen{at}usc.edu
Objective: The authors evaluated the efficacy of risperidone in reducing psychotic and aggressive symptoms in a subgroup of patients who fulfilled operationalized criteria for psychosis of dementia. Methods: Authors conducted a subgroup analysis of patients in the risperidone database arising from a previous double-blind, randomized, placebo-controlled study. In the primary study, patients age 55 or older, with a DSM-IV diagnosis of Alzheimer disease and/or vascular dementia were randomized to placebo or 0.5 mg, 1.0 mg, or 2.0 mg/day of risperidone. For this analysis, patients were selected who fulfilled operationalized criteria for psychosis of dementia. These criteria were then validated. The primary outcome measures were the newly developed Psychosis and Aggression Severity Indices, derived from Parts 1 and 2 of the BEHAVE-AD rating scale. Results: At Week 12 and endpoint, patients with psychosis of dementia receiving 1 mg or 2 mg/day of risperidone showed significantly more improvement on the Psychosis Severity and Aggressiveness Severity Indices than those receiving placebo. Conclusions: The construct of psychosis of dementia was validated, and the severity of both psychosis and aggressiveness was reduced with risperidone treatment in a robust and dose-related way, with a continuing response over the 12-week trial period.
Key Words: Alzheimer disease • neuroleptics • risperidone
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