ISRCTN57507360已完成3 期
Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 210 人开始时间: 2010年4月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
研究概览
简要总结
- 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23842010 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28383308
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Out-patients of both genders aged more than 65 years
- •2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a moderate to severe episode of a recurrent major depressive disorder
排除标准
- •1. All types of depression other than major depressive disorder recurrent
- •2. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study
- •3. Current diagnosis of neurological disorders
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