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

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo in treating mania during 3 weeks of treatment in patients with Bipolar I Disorder who suffer from manic or mixed episodes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed

• hospitalized voluntarily at study initiation for treatment of manic episode

• history (prior to study initiation) of at least one documented manic or mixed episode that required treatment

• total score >=20 on the Young Mania Rating Scale (YMRS) at start of the study

Exclusion Criteria:

• Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling

• borderline or antisocial personality disorder

• history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation

• seizure disorder

• females who are pregnant or nursing, or those lacking adequate contraception.