Overview

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