Antidepressant Therapy in Treating Bipolar Type II Major Depression
|ClinicalTrials.gov Identifier: NCT00602537|
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression||Drug: Venlafaxine Drug: Lithium Carbonate||Phase 4|
Bipolar type II (BP II) depression affects 2.5% of the U.S. adult population. People with BP II disorder do not experience the manic episodes that are characteristic of BP I disorder, but rather they experience more modest mood swings with a greater number of major depressive episodes (MDEs). These MDEs are associated with high rates of disease and death. The treatment of BP II depression remains a challenge for clinicians. Mood stabilizer (MS) monotherapy is the current recommended treatment for BD II MDE, but there is reason to believe that antidepressant drug (AD) monotherapy could also be an effective treatment. However, concerns over AD-induced manic switch episodes have limited the use of this treatment option. Preliminary studies using the ADs fluoxetine or venlafaxine have shown success in treating and lowering the manic switch rate of those with BP II MDE. This study will compare the safety and effectiveness of AD monotherapy versus MS monotherapy in treating people with BP II major depression.
Participation in this double-blind study will last up to 9 months. After screening, which includes a medical and psychiatric history review, a physical exam, an electrocardiogram (EKG) test, clinical laboratory tests, a urine-based drug test, and a pregnancy test if applicable, participants will be randomly placed into one of two treatment groups. Participants in the AD monotherapy group will be treated with venlafaxine, and participants in the MS monotherapy group will be treated with lithium. During the first 12 weeks, there will be a total of nine study visits lasting between 45 and 60 minutes. In these visits, participants will receive their study drug and will undergo various assessments, including a review of medication history and side effects, vital sign measurements, and questionnaires about depression and daily functioning. Blood samples will be taken at most visits.
Participants who respond well during the initial 12 weeks of therapy with either drug will have the option to continue treatment for 6 additional months. During this time, participants will continue their assigned treatment and will attend five monthly study visits that will repeat previous assessments and procedures.
For information on a related study, please follow this link:
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Bipolar Type II Major Depression|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
75 to 375 mg
Active Comparator: II
Mood stabilizer therapy
Drug: Lithium Carbonate
300 to 2400 mg
- Depressive Relapse [ Time Frame: Weeks 16, 20, 24, 30, 36 ]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.
- Treatment-Emergent Mood Symptoms [ Time Frame: Measured at Weeks 12 and 36 ]These subjects must be responders.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602537
|United States, Pennsylvania|
|Depression Research Unit - University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-3309|
|Principal Investigator:||Robert J. DeRubeis, PhD||University of Pennsylvania|