NCT00083954已完成3 期
A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression
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
- 530
- 试验地点
- 36
- 主要终点
- Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status
排除标准
- •More than 8 mood episodes in the past year from screen (visit 1);
- •A current Axis I disorder other than bipolar disorder within 6 months of screening;
- •patients with clinically significant abnormal laboratory findings in the investigator's judgment
结局指标
主要结局
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
次要结局
- Evaluate the incidence of treatment-emergent mania compared to placebo
研究者
研究点 (36)
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