Gao Bipolar Spectrum Lithium/Quetiapine Study

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Lithium Carbonate; Quetiapine Fumarate

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.