ISRCTN19313268已完成3 期
Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 500 人开始时间: 2008年8月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
2010 results in https://www.ncbi.nlm.nih.gov/pubmed/?term=20856123
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 to 65 years
- •2. Male or female
- •3. Out-patients
- •4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for major depressive disorder
排除标准
- •1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study
- •2. All types of depression other than major depressive disorder
- •3. Severe or uncontrolled organic disease
研究者
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