Status:
COMPLETED
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression 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 (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
Eligibility Criteria
Inclusion
- ages 18-65
- Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00080314
Start Date
January 1 2004
End Date
October 1 2006
Last Update
November 11 2013
Active Locations (28)
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1
Local Institution
Tuscaloosa, Alabama, United States
2
Local Institution
Little Rock, Arkansas, United States
3
Local Institution
San Diego, California, United States
4
Local Institution
Sherman Oaks, California, United States