NCT00122824已完成3 期
Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 8
- 主要终点
- To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score.
研究概览
简要总结
This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients at least 18 years of age
排除标准
- •Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
- •Patient diagnosed with major depressive disorder within the past 6 months
- •Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year
- •History of alcohol or any psychoactive substance abuse or dependence within the past 6 months
结局指标
主要结局
To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score.
次要结局
- Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
研究者
研究点 (8)
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