A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- MADRS Score - Overall Change From Baseline
研究概览
简要总结
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
详细描述
This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.
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
- •Currently meets DSM-5 criteria for MDD
- •Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
- •Agree to use adequate method of contraception for the duration of the study
- •Additional criteria may apply
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
- •Additional criteria may apply
研究组 & 干预措施
AXS-05
干预措施: AXS-05 (Drug)
Bupropion
干预措施: Bupropion (Drug)
结局指标
主要结局
MADRS Score - Overall Change From Baseline
时间窗: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)
The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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