A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Time from randomization to relapse of depressive symptoms
研究概览
简要总结
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
详细描述
Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.
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
- Triple (Participant, Care Provider, 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
- •Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- •Current major depressive episode of at least 4 weeks in duration
排除标准
- •Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.
- •Unable to comply with study procedures
- •Medically inappropriate for study participation in the opinion of the investigator
研究组 & 干预措施
AXS-05
AXS-05 tablets, taken twice daily
干预措施: AXS-05 (Drug)
Bupropion
Bupropion tablets, taken twice daily
干预措施: Bupropion (Drug)
结局指标
主要结局
Time from randomization to relapse of depressive symptoms
时间窗: up to 26 weeks
次要结局
未报告次要终点