Antidepressant Therapy for Bipolar II Major Depression
Acute Antidepressant Therapy in Bipolar II Major Depression
1 other identifier
interventional
90
1 country
1
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 antidepressant therapy will be superior to mood stabilizer therapy with little or no difference in treatment emergent manic symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedMarch 24, 2008
March 1, 2008
4.5 years
March 18, 2008
March 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Hamilton Depression Rating Scale score.
12 Weeks
Secondary Outcomes (1)
Change in Young Mania Rating Scale score.
12 Weeks
Study Arms (2)
1
EXPERIMENTALAntidepressant
2
ACTIVE COMPARATORDrug
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Depression Research Unit, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309, United States
Related Publications (1)
Shults J, Sun W, Tu X, Kim H, Amsterdam J, Hilbe JM, Ten-Have T. A comparison of several approaches for choosing between working correlation structures in generalized estimating equation analysis of longitudinal binary data. Stat Med. 2009 Aug 15;28(18):2338-55. doi: 10.1002/sim.3622.
PMID: 19472307DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay D Amsterdam, MD
Depression Research Unit, School of Psychiatry, University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
April 1, 2002
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
March 24, 2008
Record last verified: 2008-03