Overview
Antidepressant Therapy in Treating Bipolar Type II Major Depression
Status:
Completed
Completed
Trial end date:
2013-06-01
2013-06-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of PennsylvaniaCollaborator:
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