Gao Bipolar Spectrum Lithium/Quetiapine Study
This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder|
- Time to study discontinuation [ Time Frame: Week 16 ] [ Designated as safety issue: No ]The time for discontinuation due to all causes will be measured and used as the primary outcome measure.
- Lithium vs. Quetiapine effects on general cardiovascular disease risk and role effects on general cardiovascular disease risk and role impairment [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Lithium||
Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
|Active Comparator: Quetiapine||
Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Other Name: Seroquel
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526148
|United States, Ohio|
|University Hospitals Case Medical Center - Mood Disorders Program|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Keming Gao, MD, PhD||University Hospital Case Medical Center|