Antidepressant Therapy in Treating Bipolar Type II Major Depression (NCT00602537) | Clinical Trial Compass
CompletedPhase 4
Antidepressant Therapy in Treating Bipolar Type II Major Depression
United States140 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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