NCT00278941已完成3 期
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of 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
- 3,000
- 试验地点
- 168
- 主要终点
- To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)
研究概览
简要总结
The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo & to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction 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
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
- •Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder,
- •Single Episode, or 296.3x Major Depressive Disorder,
排除标准
- •Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,
- •Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status.
- •Patients whose current episode of depression>12 months or <4 weeks from enrollment
结局指标
主要结局
To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)
次要结局
- Evaluate quetiapine SR compared to placebo on health related quality of life.
研究者
研究点 (168)
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