ISRCTN97599615已完成3 期
Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder. A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period.
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 316 人开始时间: 2010年9月10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
- 316
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. Aged between 18 and 65 years
- •2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR) criteria for major depressive episode of moderate or severe intensity
- •3. Diagnosis documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI)
- •4. Clinical Global Impression scale
- •5. Requiring a change in antidepressant treatment due to an insufficient treatment efficacy associated or not with poor acceptability
排除标准
- •1. High suicidality according to MINI 5.0.0.
- •2. Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator's opinion
- •3. Hepatic impairment
研究者
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