Status:
COMPLETED
Study of Aripiprazole in Patients With Bipolar I Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mi...
Eligibility Criteria
Inclusion
- Clinical diagnosis of bipolar I disorder, manic or mixed episode
Exclusion
- First manic or mixed episode
- Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
- Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00257972
Start Date
October 1 2004
End Date
December 1 2007
Last Update
November 8 2013
Active Locations (90)
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1
Local Institution
Little Rock, Arkansas, United States
2
Local Institution
Riverside, California, United States
3
Local Institution
Deerfield Beach, Florida, United States
4
Local Institution
Jacksonville, Florida, United States