AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Change in MADRS Total Score From Baseline to Week 6
研究概览
简要总结
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
详细描述
This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 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
- 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
- •Age 18 - 65
- •Currently meets DSM-5 criteria for MDD
- •Body Mass Index between 18 and 40 kg/m^2, inclusive
排除标准
- •Suicide risk
- •History of treatment resistance in current depressive episode
- •History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
研究组 & 干预措施
AXS-05
AXS-05 (bupropion and dextromethorphan) oral tablets
干预措施: AXS-05 (Drug)
Placebo
Placebo oral tablets to match AXS-05
干预措施: Placebo (Drug)
结局指标
主要结局
Change in MADRS Total Score From Baseline to Week 6
时间窗: 6 weeks
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
次要结局
未报告次要终点