Gao Bipolar Spectrum Lithium/Quetiapine Study
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | January 2015 |
Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder
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.
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.
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.
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