Status:
COMPLETED
Antidepressant Therapy for Bipolar II Major Depression
Lead Sponsor:
Stanley Medical Research Institute
Conditions:
Bipolar Type II Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study examines the relative safety and benefit of antidepressant therapy (versus recommended mood stabilizer therapy)of bipolar type II major depressive episode. We hypothesize that antidepressan...
Detailed Description
Bipolar type II (BP II) major depressive episode (MDE), affects 2.5% of the US adult population and results in an estimated healthcare cost of $40 billion annually. BP II disorder is a distinct clinic...
Eligibility Criteria
Inclusion
- men and women (all races and ethnicity) greater than or equal to18 years of age,
- DSM IV diagnosis of BP II disorder,
- Current DSM IV MDE,
- HAM-D17 score greater than or equal to 16,
- Drug free from prior psychotropic medication greater than or equal to 7 days (2 weeks for MAOIs)
Exclusion
- History of mania,
- Other primary DSM IV Axis I diagnosis,
- Alcohol or drug dependence within 3 months,
- History of nonresponse to Effexor-XR or lithium in the present MDE,
- History of allergic reaction to Effexor-XR or lithium,
- Medical contraindications to treatment with Effexor-XR or lithium,
- Unstable medical condition,
- Pregnant or breast-feeding women,
- Women of child-bearing potential not using a medically approved form of contraception,
- Actively suicidal or requiring hospitalization,
- Requiring concurrent antidepressant, neuroleptic or mood stabilizer therapy,
- Prior investigational study within 4 weeks of starting active therapy.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00641927
Start Date
April 1 2002
End Date
October 1 2006
Last Update
March 24 2008
Active Locations (1)
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1
Depression Research Unit, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309