Antidepressant Therapy for Bipolar II Major Depression

Completed · Phase 4

Conditions studied: Bipolar Type II Disorder

In brief

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.

Key facts

Study ID: NCT00641927
Run by: Stanley Medical Research Institute
People needed: 90
Starts: 2002-04-01
Expected to finish: 2006-10-01
Last updated by the study team: 2008-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Depression Research Unit, Department of Psychiatry, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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