Combination Therapy for the Treatment of Bipolar Disorders
This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Combination Therapy in Bipolar Rapid Cycling|
|Study Start Date:||February 2002|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.
Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.
|United States, Ohio|
|University Hospitals of Cleveland|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Keming Gao, MD, PhD||Case Western Reserve University / University Hospitals of Cleveland|