Antidepressant Therapy for Bipolar II Major Depression

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanley Medical Research Institute
• Treatments: Antidepressive Agents; Lithium Carbonate; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.