NCT00606541终止早期 1 期
An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)
研究概览
简要总结
Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults 18-65 years of age
- •A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
- •Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
- •Written informed consent
- •A 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, mental retardation or other pervasive developmental 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 within 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
- •Subjects needing concurrent use of psychotropic medications
- •History of hypersensitivity to quetiapine
- •History of cataracts.
研究组 & 干预措施
1
Experimental
Quetiapine XR 50mg-400mg per day
干预措施: Quetiapine XR (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)
时间窗: 20 weeks
次要结局
- Percentage of CGI-I, BSPS, SPIN(20 weeks)
研究者
研究点 (1)
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