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

Outcome

Met primary endpoint

paper Improvement in mean Young Mania Rating Scale total score (adjusted for covariates) was significantly greater in the risperidone than in the placebo group at endpoint PMID 15169694 ↗

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