Bipolar Disorder | Gao Bipolar Spectrum Lithium/Quetiapine Study
Bipolar Disorder research study
What is the primary objective of this 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.
Who is eligible to participate?
Inclusion Criteria: - Able to provide informed consent before beginning any study-specific procedures - Male and female patients at least 18 years of age - Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s) - Willing to be randomized to either Lithium or Quetiapine - If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation - Women with reproductive potential must have a negative urine pregnancy test Exclusion Criteria: - Unwilling to comply with study requirements - Patients who have had severe adverse reaction to Lithium or Quetiapine - Patients who require inpatient care - Drug/alcohol dependence requiring immediate acute detoxification - Pregnancy as determined by serum pregnancy test or breastfeeding - History of nonresponse to Lithium at doses >900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LithiumLithium 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.
Drug:QuetiapineQuetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2012
Completed Date: January 2015
Phase: Phase 4
Primary Outcome: Time to Study Discontinuation
Secondary Outcome: Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Study sponsors, principal investigator, and references
Principal Investigator: Keming Gao, MD, PhD
Lead Sponsor: University Hospitals Cleveland Medical Center