Antidepressant Therapy in Treating Bipolar Type II Major Depression

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.

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

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antidepressive Agents; Lithium Carbonate; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for Axis I bipolar II disorder

• Meets DSM-IV criteria for Axis I major depressive episode

• Score of 16 on 17-item HAM-D rating scale

• Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry

• Willing to use an effective form of birth control throughout the study

Exclusion Criteria:

• History of mania

• Current primary Axis I diagnosis other than bipolar II disorder

• Alcohol or drug dependence within 3 months prior to study entry

• Contraindication to treatment with venlafaxine or lithium

• Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)

• Pregnant or breastfeeding

• Experiencing suicidal thoughts

• Requires hospitalization

• Requires concurrent neuroleptic or MS therapy

• Requires concurrent AD therapy

• Current psychotic features

• Inadequate trial of therapy at the time of initial screening visit

• History of intolerance to either venlafaxine or lithium

• Unlikely to participate in a 36-week trial

• Presence of apparent secondary gain