NCT00514865已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Change from baseline to treatment endpoint in the MADRS total score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with recurrent major depressive disorder
排除标准
- •Patients with treatment resistance for depression
- •History of alcohol abuse/dependence, substance abuse/dependence within 6 months
- •Has clinically significant unstable medical condition
- •Has significant risk of suicide
研究组 & 干预措施
Experimental 1
Experimental
1-2 mg of ONO-2333
干预措施: ONO-2333Ms Experimental 1 (Drug)
Experimental 2
Experimental
5-10 mg of ONO-2333
干预措施: ONO-2333Ms Experimental 2 (Drug)
Placebo
Placebo Comparator
placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to treatment endpoint in the MADRS total score
时间窗: 8 weeks
次要结局
- Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score(8 weeks)
研究者
研究点 (1)
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