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

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) 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.

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

Details

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

Criteria

Inclusion Criteria:

• Meets diagnosis criteria for Bipolar I Disorder - Most Recent Episode Manic (Diagnostic and Statistical Manual of Mental Diseases, 4th edition, (DSM-IV))

• meets DSM-IV criteria for a current manic episode

• hospitalized voluntarily at study initiation

• history of at least one documented manic or mixed episode prior to study initiation

• total score of >=20 on the Young Mania Rating Scale (YMRS) and total score of <=20 on the Montgomery Asberg Depression Rating Scale (MADRS) 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.