ISRCTN49376288已完成3 期
Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks.
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 300 人开始时间: 2007年6月8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
- 300
研究概览
简要总结
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20193645
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female
- •2. Out-patients
- •3. Aged of 18 to 60 years (inclusive)
- •4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria for major depressive disorder
- •5. Requiring an antidepressant treatment
排除标准
- •1. Pregnant or breastfeeding, women of childbearing potential without effective contraception
- •2. All types of depression other than major depressive disorder
- •3. Severe or uncontrolled disease
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