drugset / Trial / NCT00250367

A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.

NCT00250367

Phase 3 Completed 151 enrolled Janssen Pharmaceutica N.V., Belgium
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the treatment of manic episodes associated with bipolar disorder.

Timeline

Start
1997-10
Primary completion
Completion
1999-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 6 mg Oral