NCT00326144已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder
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
- 310
- 试验地点
- 34
- 主要终点
- To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
研究概览
简要总结
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders 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
- Double (Participant, Investigator)
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
- •Patient is able to provide written informed consent before beginning any study related procedures
- •Patient has a documented clinical diagnosis of major depressive disorder
- •Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
排除标准
- •Patients with a history of non-compliance as judged by the study investigator
- •Patients with a known lack of response to previous treatment with quetiapine
- •Patients who have participated in a clinical trial within 4 weeks of randomization
结局指标
主要结局
To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
次要结局
- To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo
- To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo
研究者
研究点 (34)
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