Acute Treatment of Bipolar II Depression
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Acute Treatment of Bipolar II Depression|
- Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
- Incidence and severity of hypomanic and depressive symptoms [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
- Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12) [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
- Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
|Experimental: 1 Lithium||
Participants will receive lithium.
|Experimental: 2 Lamotrigine||
Participants will receive lamotrigine.
Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.
Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074776
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390-9121|
|Principal Investigator:||Trisha Suppes, MD, PhD||Stanford University|