A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 508
- 试验地点
- 40
- 主要终点
- Time from randomization to relapse of depressive symptoms
研究概览
简要总结
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.
详细描述
The study will consist of a screening period, an open label solriamfetol treatment period, a double-blind randomized withdrawal period, and a follow-up period. Eligible subjects will be treated with open-label solriamfetol and monitored for clinical response. Subjects achieving clinical response will be randomized into the double-blind randomized withdrawal period in a 1:1 ratio to either continued treatment with solriamfetol or to switch to placebo, for the remainder of the double-blind period or until they experience relapse of depressive symptoms.
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
- •Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
- •Excessive daytime sleepiness symptoms
- •Able to comply with study procedures
- •Male or female, aged 18 to 65 years inclusive
排除标准
- •Any clinically significant medical (e.g., OSA, narcolepsy), behavioral, or psychiatric disorder, other than MDD with EDS symptoms
- •Unable to comply with study procedures
- •Medically inappropriate for study participation in the opinion of the investigator
研究组 & 干预措施
Placebo
• In the randomized double-blind period (if applicable)
干预措施: Placebo (Drug)
Solriamfetol 150mg
- In the open-label period;
- In the randomized double-blind period (if applicable)
干预措施: Solriamfetol 150 MG (Drug)
结局指标
主要结局
Time from randomization to relapse of depressive symptoms
时间窗: Up to 24 weeks.
次要结局
未报告次要终点