Depression Clinical Trial
Official title:
Treatment of Bipolar Type II Major Depression
Verified date | April 2017 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.
Status | Completed |
Enrollment | 140 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Depression Research Unit - University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depressive Relapse | These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered "depressive relapse" if relapsed by any of these times. | Weeks 16, 20, 24, 30, 36 | |
Secondary | Treatment-Emergent Mood Symptoms | These subjects must be responders. | Measured at Weeks 12 and 36 |
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