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

Phase 3

Withdrawn

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

• Registration Number: NCT00338273
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-20
• Study Start: 2006-12
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2012-02
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Outpatients
• Must sign informed consent prior to protocol-related procedures

Exclusion Criteria

• Women who are pregnant, trying to become pregnant, or nursing
• Significant risk of committing suicide
• Any serious unstable medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Aripiprazole	-
A2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

Trial Locations

Locations (1)

Local Institution; 🇮🇳 Vishakhapatnam, India