Status:
COMPLETED
Prevention of Relapse & Recurrence of Bipolar Depression
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the long-term use of combined antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in preventing the relapse and r...
Detailed Description
Recurrence of Bipolar I (BP I) major depressive episode (MDE), is now recognized as a major mental health problem. Recurrent BP I MDE is a disorder with no satisfactory therapy, and its treatment rema...
Eligibility Criteria
Inclusion
- Men/women (all races and ethnicity)
- Age at least 18 years old
- Bipolar Type I Disorder
- Current Major Depressive Episode
- Able to understand and provide signed informed consent
Exclusion
- Current alcohol or drug abuse
- Alcohol or drug dependence within 3 months
- Allergic to Fluoxetine or Lithium
- Unstable medical condition (e.g., uncontrolled thyroid, renal, cardiovascular disease)
- Pregnant or nursing women
- Women of child-bearing potential unwilling to use a medically acceptable form of contraception
- Actively suicidal
- Requiring hospitalization
- Use of medication contraindicated with lithium or fluoxetine
- Unable to participate in a year-long trial
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00961961
Start Date
July 1 2009
End Date
September 1 2016
Last Update
October 19 2020
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Depression Research Unit
Philadelphia, Pennsylvania, United States, 19104-3309