Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Time to Study Discontinuation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Lithium
干预措施: Lithium (Drug)
Quetiapine
干预措施: Quetiapine (Drug)
结局指标
主要结局
Time to Study Discontinuation
时间窗: 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
次要结局
- 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)
研究者
Keming Gao
Director, Mood & Anxiety Clinic
University Hospitals Cleveland Medical Center