ISRCTN28588282已完成未知
Efficacy and safety of agomelatine given orally compared to placebo, in addition to a mood stabiliser in bipolar I patients with a current major depressive episode. An eight week randomised, double-blind, controlled, parallel group study followed by a double-blind extension treatment period up to one year
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 300 人开始时间: 2006年8月24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
- 300
研究概览
简要总结
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/25999335
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients of both genders, over 18 years old
- •2. Fulfilling The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for bipolar I disorder with current major depressive episode
- •3. Treated with a mood stabiliser
排除标准
- •1. Hepatic or renal failure
- •2. Abnormal thyroid function
- •3. Pregnancy
- •4. Other psychiatric conditions according to DSM-IV TR
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