An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 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
- 825
- 试验地点
- 1
- 主要终点
- Change from baseline in the 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 or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine 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
研究组 & 干预措施
Saredutant 100mg and Paroxetine 20 mg
combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
干预措施: saredutant (SR48968) (Drug)
Saredutant 100mg and Paroxetine 20 mg
combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
干预措施: paroxetine (Drug)
Saredutant 30mg and Paroxetine 20mg
combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
干预措施: saredutant (SR48968) (Drug)
Saredutant 30mg and Paroxetine 20mg
combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
干预措施: paroxetine (Drug)
Paroxetine 20 mg and saredutant placebo
paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
干预措施: paroxetine (Drug)
Paroxetine 20 mg and saredutant placebo
paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
干预措施: placebo (Drug)
Placebo
Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
时间窗: 8 weeks
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score
时间窗: weeks
次要结局
- Change from baseline in the Clinical Global Impression severity of illness score(8 weeks)
- Change from baseline in the HAM-D depressed mood item scores(8 weeks)