Phase 4
N=129
Antidepressant Therapy in Treating Bipolar Type II Major Depression
Bipolar Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00602537 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Depressive Relapse — 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Venlafaxine (Drug); Lithium Carbonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Relapse |
3; 4 | — |
| SECONDARY Treatment-Emergent Mood Symptoms |
15; 11; 3; 3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00602537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.