Phase 4
Completed N=129
Antidepressant Therapy in Treating Bipolar Type II Major Depression
Source: ClinicalTrials.gov NCT00602537 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Depressive Relapse — 3; 4 Participants
◆ Published Evidence
Established
53citations · ~5 / year
Short-term venlafaxine v. lithium monotherapy for bipolar type II major depressive episodes: effectiveness and mood conversion rate.
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.
Linked Publications (5)
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Short-term venlafaxine v. lithium monotherapy for bipolar type II major depressive episodes: effectiveness and mood conversion rate.
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Step-wise loss of antidepressant effectiveness with repeated antidepressant trials in bipolar II depression.
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Residual anxiety may be associated with depressive relapse during continuation therapy of bipolar II depression.
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Effects of venlafaxine versus lithium monotherapy on quality of life in bipolar II major depressive disorder: Findings from a double-blind randomized controlled trial.
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Comparison of treatment outcome using two definitions of rapid cycling in subjects with bipolar II disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Relapse |
3; 4 | — |
| SECONDARY Treatment-Emergent Mood Symptoms |
15; 11; 3; 3 | — |
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) and the linked publication. 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. Informational only — not medical advice.