Study of Aripiprazole in Patients With Bipolar I Disorder

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00257972
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-11-23
• Study First Submitted QC: 2005-11-23
• Study First Posted: 2005-11-24
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-05
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in a mania rating scale

Secondary Outcome Measures

Name	Time	Method
Response rate and Clinical Global Impression Scale at endpoint

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Surbiton, Middlesex, United Kingdom