Antidepressant Therapy in Treating Bipolar Type II Major Depression
|Bipolar Disorder Depression||Drug: Venlafaxine Drug: Lithium Carbonate||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Treatment of Bipolar Type II Major Depression|
- 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.
|Study Start Date:||December 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
75 to 375 mg
Active Comparator: II
Mood stabilizer therapy
Drug: Lithium Carbonate
300 to 2400 mg
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:
Please refer to this study by its ClinicalTrials.gov identifier: 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|