Study of Aripiprazole in Patients With Bipolar I Disorder

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion Criteria:

• First manic or mixed episode

• Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole

• Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole