Status:
COMPLETED
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Eligibility Criteria
Inclusion
- Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic
Exclusion
- First manic episode
- Current manic or mixed episode with \> 2 years duration
- Treated with aripiprazole within the past 3 months
- Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1169 Patients enrolled
Trial Details
Trial ID
NCT00277212
Start Date
December 1 2005
End Date
July 1 2009
Last Update
December 2 2013
Active Locations (66)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35205
2
Southwest Biomedical Research Foundation
Tucson, Arizona, United States, 85712
3
Pravin Kansagra, M.D.
Anaheim, California, United States, 92801
4
College Hospital Costa Mesa
Costa Mesa, California, United States, 92627