Gao Bipolar Spectrum Lithium/Quetiapine Study

Phase 4

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Lithium	Lithium	-
Quetiapine	Quetiapine	-

Primary Outcome Measures

Name	Time	Method
Time to Study Discontinuation	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 Outcome Measures

Name	Time	Method
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	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.