Antidepressant Therapy in Treating Bipolar Type II Major Depression
Treatment of Bipolar Type II Major Depression
2 other identifiers
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedApril 25, 2017
April 1, 2017
5.5 years
January 15, 2008
November 10, 2016
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Treatment-Emergent Mood Symptoms
Measured at Weeks 12 and 36
Study Arms (2)
I
EXPERIMENTALAntidepressant therapy
II
ACTIVE COMPARATORMood stabilizer therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309, United States
Related Publications (7)
Lorenzo-Luaces L, Amsterdam JD, DeRubeis RJ. Residual anxiety may be associated with depressive relapse during continuation therapy of bipolar II depression. J Affect Disord. 2018 Feb;227:379-383. doi: 10.1016/j.jad.2017.11.028. Epub 2017 Nov 8.
PMID: 29149756DERIVEDLorenzo-Luaces L, Amsterdam JD. Effects of venlafaxine versus lithium monotherapy on quality of life in bipolar II major depressive disorder: Findings from a double-blind randomized controlled trial. Psychiatry Res. 2018 Jan;259:455-459. doi: 10.1016/j.psychres.2017.11.025. Epub 2017 Nov 8.
PMID: 29136600DERIVEDAmsterdam JD, Lorenzo-Luaces L, DeRubeis RJ. Comparison of treatment outcome using two definitions of rapid cycling in subjects with bipolar II disorder. Bipolar Disord. 2017 Feb;19(1):6-12. doi: 10.1111/bdi.12462. Epub 2017 Feb 3.
PMID: 28160351DERIVEDAmsterdam JD, Lorenzo-Luaces L, DeRubeis RJ. Step-wise loss of antidepressant effectiveness with repeated antidepressant trials in bipolar II depression. Bipolar Disord. 2016 Nov;18(7):563-570. doi: 10.1111/bdi.12442. Epub 2016 Nov 2.
PMID: 27805299DERIVEDAmsterdam JD, Lorenzo-Luaces L, Soeller I, Li SQ, Mao JJ, DeRubeis RJ. Short-term venlafaxine v. lithium monotherapy for bipolar type II major depressive episodes: effectiveness and mood conversion rate. Br J Psychiatry. 2016 Apr;208(4):359-65. doi: 10.1192/bjp.bp.115.169375. Epub 2016 Feb 18.
PMID: 26892848DERIVEDLorenzo-Luaces L, Amsterdam JD, Soeller I, DeRubeis RJ. Rapid versus non-rapid cycling bipolar II depression: response to venlafaxine and lithium and hypomanic risk. Acta Psychiatr Scand. 2016 Jun;133(6):459-69. doi: 10.1111/acps.12557. Epub 2016 Jan 24.
PMID: 26803764DERIVEDAmsterdam JD, Lorenzo-Luaces L, Soeller I, Li SQ, Mao JJ, DeRubeis RJ. Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study. J Affect Disord. 2015 Oct 1;185:31-7. doi: 10.1016/j.jad.2015.05.070. Epub 2015 Jun 26.
PMID: 26143402DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jay Amsterdam
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J. DeRubeis, PhD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 28, 2008
Study Start
December 1, 2007
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
April 25, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share