ISRCTN75061806已完成未知
Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder: a randomised controlled trial
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 510 人开始时间: 2012年8月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Asian patients aged 18 years
- •2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder diagnosis confirmed by the M.I.N.I. questionnaire and requiring a psychotropic treatment.
- •3. Hamilton Anxiety Scale (HAM-A) total score >22
排除标准
- •1. All types of current anxiety disorders (within 6 months prior to the selection visit) other than generalized anxiety disorder (GAD)
- •2. Current diagnosis of any other psychiatric disorders than GAD or severe or uncontrolled organic disease
- •3. Any clinically relevant abnormality detected during the physical examination, ECG, liver B ultrasound exams or laboratory tests likely to interfere with the study conduct or evaluations
- •4. Pregnancy or breastfeeding women
研究者
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