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临床试验/NCT00254735
NCT00254735已完成3 期

Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study

AstraZeneca2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2002年4月1日最近更新:
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

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

发起方
AstraZeneca
申办方类型
Industry

研究点 (2)

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