Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder
Overview
- Phase
- Phase 4
- Intervention
- Lithium
- Conditions
- Bipolar Disorder
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Time to Study Discontinuation
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Keming Gao
Director, Mood & Anxiety Clinic
University Hospitals Cleveland Medical Center
Eligibility Criteria
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.
Arms & Interventions
Lithium
Intervention: Lithium
Quetiapine
Intervention: Quetiapine
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Screening and Week 16)