Study of Aripiprazole in Patients With Acute Bipolar Mania

Phase 3

Completed

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

• Registration Number: NCT00097266
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-11-19
• Study First Submitted QC: 2004-11-19
• Study First Posted: 2004-11-22
• Study Start: 2004-12
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2010-07
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

• Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	-
B	Aripiprazole	-
C	Haloperidol	-

Primary Outcome Measures

Name	Time	Method
Change in a mania rating scale at endpoint

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇿🇦 Berea, Kwa Zuluu Natal, South Africa