EUCTR2005-004881-17-AT进行中（未招募）不适用
Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- In or out patients of both genders,
- •- over 18 years old,
- •- fulfilling DSM-IV-TR criteria for Bipolar I disorder with current Major Depressive Episode
- •- Treated with a mood stabilizer (lithium or valproic acid).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Other psychiatric conditions according to DSM-IV TR,
- •- Pregnancy (positive ßhCG blood test),
- •- Use of psychotropic medications other than lithium, valproic acid and lorazepam.
研究者
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