EUCTR2011-002160-24-SK进行中（未招募）不适用
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment - ARTDeCo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
- •A primary diagnosis of MDD without psychotic features
- •Having inadequate response to current antidepressant treatment
- •Having at least 1 but no more than 2 antidepressant treatment trial failures within the index depressive episode
- •Index depressive episode started within 1 year
- •18 up to 65 years of age
- •BMI between 18.0 to 35.0 kg/m2 inclusive
- •Patients with reproductive potential must agree to use specified contraceptive protection
- •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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •Previously received RO4995819
- •History of non-response to, or current use of a non-pharmacological treatment
- •Present DSM-IV-TR axis I diagnosis except anxiety comorbidity
- •Past or present psychotic symptoms
- •Mood disorder due to medical condition or substance use/abuse/dependence
- •Established personality disorder
- •Alcohol and/or substance abuse/dependence
- •A current (at screening) significant risk for suicidal behavior as judged by the Investigator following a thorough clinical evaluation and supported by information collected on the C-SSRS
- •Significant or unstable other medical condition that could interfere with the conduct of the study
研究者
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