A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 41
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.
详细描述
Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) 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
- 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 the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
- •Current major depressive episode
- •Male or female, aged 18 to 65 inclusive
排除标准
- •Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
- •Unable to comply with study procedures
- •Medically inappropriate for study participation in the opinion of the investigator
研究组 & 干预措施
Solriamfetol 300 mg
Up to 6 weeks
干预措施: Solriamfetol 300 mg (Drug)
Placebo
Up to 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 6 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: 6 weeks
次要结局
未报告次要终点