An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 643
- 试验地点
- 1
- 主要终点
- Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with recurrent Major Depressive Disorder
排除标准
- •Symptoms of current depressive episode for less than 30 days or more than 2 years
- •Mild depression, as measured by standard clinical research scales
- •Significant suicide risk
- •Lack of sexual activity (including masturbation)
- •Other psychiatric conditions that would obscure the results of the study
- •History of failure to respond to antidepressant treatment
- •Pregnancy or breast-feeding
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Saredudant/Escitalopram
Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
干预措施: saredutant (SR48968) (Drug)
Saredudant/Escitalopram
Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
干预措施: escitalopram (Drug)
Placebo and Escitalopram
Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
干预措施: escitalopram (Drug)
Placebo and Escitalopram
Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
干预措施: placebo (Drug)
Placebo
Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
时间窗: Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
时间窗: Baseline, Day 56
次要结局
- Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score(Baseline, Day 56)
- Change from baseline to Day 56 in HAM-D depressed mood item scores.(Baseline, Day 56)
- Percentage of patients demonstrating a treatment response(Day 56)