Status:

WITHDRAWN

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

Lead Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborating Sponsors:

Otsuka America Pharmaceutical

Conditions:

Bipolar Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2007

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00338273

Start Date

December 1 2006

End Date

November 1 2007

Last Update

November 8 2013

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Local Institution

Durham, North Carolina, United States

2

Local Institution

Ahmedabad, Gujarat, India

3

Local Institution

Chennai, India

4

Local Institution

Delhi, India