NCT00320268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®) as Monotherapy in the Treatment of Patients With MDD
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
- 600
- 试验地点
- 37
- 主要终点
- Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
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
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 has a documented clinical diagnosis of Major Depressive Disorder.
- •Be able to understand and comply with the requirements of the study.
- •Able to understand and provide written informed consent
排除标准
- •Patients (female) must not be pregnant or lactating
- •Current or past diagnosis of stroke or transient ischemic attack (TIA).
结局指标
主要结局
Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
次要结局
- Change from randomization to each assessment in the MADRS total score
- MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6
研究者
研究点 (37)
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