NCT01273376已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With 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
- 314
- 试验地点
- 5
- 主要终点
- Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
研究概览
简要总结
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control
- •Depressive episode duration of less than 1 month
- •Lifetime history of any psychotic disorders
- •Anxiety disorders
- •Significant suicidality
- •Clinically significant medical conditions
研究组 & 干预措施
RX-10100 high dose
Experimental
RX-10100
Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
干预措施: RX-10100 (Drug)
RX-10100 low dose
Experimental
RX-10100
Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
干预措施: RX-10100 (Drug)
Placebo
Placebo Comparator
Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
干预措施: RX-10100 (Drug)
结局指标
主要结局
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
时间窗: 8 weeks
次要结局
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7(8 weeks)
研究者
研究点 (5)
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