A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: Placebo; Drug: Aripiprazole

• Registration Number: NCT00094432
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-10-18
• Study First Submitted QC: 2004-10-18
• Study First Posted: 2004-10-19
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-06
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Men and women, ages 18-65
• Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Placebo	-
A1	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to endpoint on the MADRS total score.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Bipolar Version
Severity of illness score depression
Mean change from baseline to endpoint

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Charleston, West Virginia, United States