EUCTR2011-002362-21-ES进行中（未招募）不适用
A randomised, double-blind, parallel-group, active-controlled, flexible dose study evaluating the effects of Lu AA21004 versus agomelatine in adult patients suffering from major depressive disorder with inadequate response to antidepressant treatment
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •?The patient is a man or woman, between 18 and 75 years old (inclusive)
- •?The patient is being treated with an SRI antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
- •?The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
- •?MADRS total score ?22 at the Screening Visit and Baseline
- •?The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception
- •Other protocol-defined inclusion criteria may apply
- •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 395
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •?The patient has any current Axis I disorders (DSM-IV criteria) other than MDD, GAD and SAD
- •?The patient is at significant risk of suicide
- •?The patient is currently receiving formal psychotherapy or otherpsychoactive medications
- •Other protocol-defined exclusion criteria may apply
研究者
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