A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Change in the MADRS10 Total Score From Baseline to Day 28
研究概览
简要总结
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a monotherapy for Major Depressive Disorder.
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
- •Adults 18 to 65 years, inclusive.
- •Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
- •Current major depressive episode.
排除标准
- •Any current and primary psychiatric disorder other than Major Depressive Disorder.
- •Severe alcohol or substance use disorder.
- •History of bipolar I and II disorder, psychosis, and/or mania.
- •Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
- •Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
研究组 & 干预措施
REL-1017
A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017.
干预措施: REL-1017 (Drug)
Placebo
Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the MADRS10 Total Score From Baseline to Day 28
时间窗: Day 28
Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
次要结局
- MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28(Day 28)
- MADRS10 Remission Rate (Total Score ≤10) at Day 28(Day 28)