NCT00322595已完成3 期
An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)
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
- 800
- 试验地点
- 86
- 主要终点
- To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).
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
- •Male or female aged 18 to 65 years;
- •A diagnosis of generalized anxiety disorder;
- •Absence of current episode of major depression.
排除标准
- •The presence or history of schizophrenia and other psychotic disorders;
- •Hypertension;
- •A current diagnosis of cancer, unless in remission for at least 5 years
结局指标
主要结局
To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
次要结局
- To evaluate efficacy by evaluating response rate.
研究者
研究点 (86)
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