A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol

Summary

The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) compared with placebo after 3 weeks of treatment in patients with bipolar disorder who are experiencing manic episodes. A secondary purpose of the study is to assess the maintenance of risperidone effectiveness versus haloperidol (an antipsychotic medication) after 12 weeks of treatment.

Timeline

Start

2001-03

Primary completion

—

Completion

2002-09

Outcome

Met primary endpoint

paper At week 3, mean Young Mania Rating Scale (YMRS) score reductions from baseline were significantly greater in patients receiving risperidone than placebo (p<0.001). PMID 15572276 ↗

Publications

• Results Smulevich AB, Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F. Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. Eur Neuropsychopharmacol. 2005 Jan;15(1):75-84. doi: 10.1016/j.euroneuro.2004.06.003.

Drugs

Indications