Aripiprazole in Patients With Acute Mania

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00095511
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-11-05
• Study First Submitted QC: 2004-11-05
• Study First Posted: 2004-11-08
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-05
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

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

Inclusion Criteria

• Primary diagnosis of Acute Bipolar I Mania

Exclusion Criteria

• Patients with a DSM-IV diagnosis other than Bipolar I Mania

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 (2)

Local Institution; 🇺🇸 Arlington, Virginia, United States

Local Institition; 🇺🇸 Shreveport, Louisiana, United States