Gao Bipolar Spectrum Lithium/Quetiapine Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01526148|
Recruitment Status : Terminated (Ran out of funding)
First Posted : February 3, 2012
Results First Posted : October 30, 2015
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Lithium Drug: Quetiapine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
|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
- Time to Study Discontinuation [ Time Frame: Week 16 ]The time, as measured in number of days, 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 as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: Screening and Week 16 ]Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526148
|United States, Ohio|
|University Hospitals Cleveland Medical Center - Mood Disorders Program|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Keming Gao, MD, PhD||University Hospitals Cleveland Medical Center|