Status:
TERMINATED
Gao Bipolar Spectrum Lithium/Quetiapine Study
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01526148
Start Date
January 1 2012
End Date
January 1 2015
Last Update
August 16 2017
Active Locations (1)
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1
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106