NCT00803361已完成3 期
Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
研究概览
简要总结
This is a 15 week study comparing how well duloxetine and placebo treatments improve 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Psychiatric Diagnosis of generalized anxiety disorder (GAD)
- •Outpatients
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
- •Clinical Global Impression (CGI) of Severity Score of at least moderate
- •Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12
排除标准
- •Pregnancy or breast feeding
- •Serious medical illness
- •Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
- •panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
- •lifetime history of bipolar or psychosis
- •Any unstable serious medical condition for which duloxetine would not be allowed
- •Any use of medications that are not allowed
研究组 & 干预措施
Duloxetine
Experimental
干预措施: Duloxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
时间窗: Baseline, Week 15
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
次要结局
- Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint(Baseline, Week 15)
- Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint(Week 15)
- Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint(Baseline, Week 15)
- Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores(Baseline, Week 15)
- Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint(Baseline, Week 15)
- Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint(Baseline, Week 15)
研究者
研究点 (1)
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