A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder

Phase 3 Completed 267 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo during 3 weeks of treatment of mania in patients with Bipolar I Disorder who are suffering a manic episode.

Timeline

Start: 2000-12
Primary completion: —
Completion: 2002-05

Publications

Results Hirschfeld RM, Keck PE Jr, Kramer M, Karcher K, Canuso C, Eerdekens M, Grossman F. Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry. 2004 Jun;161(6):1057-65. doi: 10.1176/appi.ajp.161.6.1057.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	—	Oral

A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder

Summary

Timeline

Publications

Drugs

Indications