NCT01108393已完成2 期
Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/Day After 8 Weeks of Treatment) Given Orally During 16 Weeks in Patients With Obsessive-Compulsive Disorder. A Randomised, Double-blind, Placebo-controlled, Parallel Groups, International Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Y-BOCS total score
研究概览
简要总结
The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.
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 (Participant, Investigator)
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
- •Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),
- •Y-BOCS total score ≥ 20,
- •duration of OCD symptoms of at least one year.
排除标准
- •Bipolar disorder, Schizophrenic or Psychotic Disorder
- •Severe or uncontrolled organic diseases
- •Neurological disorder
- •Women of childbearing potential who are not using effective contraception
研究组 & 干预措施
Agomelatine A
Experimental
干预措施: Agomelatine A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Y-BOCS total score
时间窗: 16 weeks
Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.
次要结局
- NIMH-OC score(16 weeks)
- MADRS total score(16 weeks)
研究者
研究点 (1)
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