NCT00254735已完成3 期
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study
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
- 44
- 试验地点
- 2
- 主要终点
- Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.
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
- •Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine
排除标准
- •Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses
结局指标
主要结局
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
次要结局
- Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
- Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.
研究者
研究点 (2)
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