NCT00314184已完成3 期
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,255
- 试验地点
- 95
- 主要终点
- Time from randomization to recurrence of a mood event
研究概览
简要总结
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Signed informed consent
- •18 years or older
- •A diagnosis of Bipolar I Disorder
- •Have a current manic, depressed or mixed episode
- •Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
- •Female patients of childbearing potential must be using a reliable method of contraception
排除标准
- •Pregnancy
- •Substance or alcohol dependence at enrollment
- •Unstable thyroid function
- •Unstable Diabetes
- •Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
- •Use of an experimental drug within 30 days of enrollment
结局指标
主要结局
Time from randomization to recurrence of a mood event
次要结局
- Time from randomization to recurrence of a manic event
- Time from randomization to recurrence of a depressed event
研究者
研究点 (95)
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