A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Behavioral Disturbances in Patients With Dementia

Summary

The purpose of the study is to evaluate the safety and efficacy of risperidone (an antipsychotic medication) versus placebo in the treatment of behavioral disturbances associated with dementia.

Timeline

Start

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Primary completion

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Completion

1997-03

Outcome

Met primary endpoint

paper At endpoint, significantly greater reductions in BEHAVE-AD total scores PMID 10084637 ↗

paper patients receiving 1 and 2 mg/day of risperidone than in placebo patients (p = .005 and p < .001, respectively). PMID 10084637 ↗

Publications

• Results Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group. J Clin Psychiatry. 1999 Feb;60(2):107-15. doi: 10.4088/jcp.v60n0207.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	0.5 mg	Oral
Subject	Risperidone	Other / unclassified	1 mg	Oral
Subject	Risperidone	Other / unclassified	2 mg	Oral

Indications