Gao Bipolar Spectrum Lithium/Quetiapine Study

University Hospitals (UH)

Status and phase

Terminated

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Quetiapine

Drug: Lithium

Study type

Interventional

Funder types

Other

Identifiers

NCT01526148

09-11-01

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.