NCT00215254已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Brief Social Phobia Scale (BSPS)
研究概览
简要总结
The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.
详细描述
This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult outpatients 18-65 years of age
- •primary diagnosis of social anxiety disorder, using DSM-IV criteria
- •minimum CGI severity score of 4 at baseline
- •minimum BSPS score of 20 at baseline
- •written informed consent
- •negative serum pregnancy test for women of childbearing potential
排除标准
- •current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
- •any current primary anxiety disorder other than SAD or current primary depression
- •history of substance abuse or dependence with the last 6 months
- •suicide risk or serious suicide attempt within the last year
- •clinically significant medical condition or laboratory abnormality
- •women of childbearing potential who are unwilling to practice an acceptable method of contraception
- •concomitant medication use for psychotropic purposes
- •history of hypersensitivity to quetiapine
结局指标
主要结局
Brief Social Phobia Scale (BSPS)
次要结局
- Clinical Global Impressions of Severity (CGI-S)
- Clinical Global Impressions of Improvement (CGI-I)
- Social Phobia Inventory (SPIN)
- Hospital Anxiety and Depression Scale (HADS)
- Connor Davidson Resilience Scale (CD-RISC)
- Sheehan Disability Inventory (SDI)
- Barnes Akathisis Scale (BAS)
- Simpson-Angus Scale (SAS)
研究者
研究点 (2)
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