A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
研究概览
简要总结
Primary Objective:
- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder.
- To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder.
- To evaluate plasma concentrations of SSR149415.
详细描述
The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free, screening and baseline period. Segment B was a 4-week, double-blind period. After the last dose of double-blind study medication in Segment B, all patients had to enter Segment C, a 1-week drug-free, follow-up period.
The total study duration for one patient participating in all segments of the study was 6 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Twice daily
干预措施: Placebo (Drug)
SSR149415 - 100mg
Twice daily
干预措施: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) (Drug)
SSR149415 - 250mg
Twice daily
干预措施: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) (Drug)
结局指标
主要结局
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
时间窗: 4 weeks
次要结局
- Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing(4 weeks)
- Number of patients with adverse events(Up to 6 weeks)
- Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores(Baseline, 4 weeks)
- Changes Clinical Global Impression (CGI) Severity and Improvement scores(Baseline, 4 weeks)