A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 37
- 主要终点
- Change in MADRS Total Score From Baseline to Day 28
研究概览
简要总结
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
详细描述
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 an adjunctive treatment of Major Depressive Disorder in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.
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
- •Body mass index (BMI) between 18.0 and 35.0 kg/m
- •Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- •Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.
排除标准
- •Psychiatric hospitalization during the current major depressive episode.
- •History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
- •Participants who, in the Investigator's judgment, are at significant risk for suicide.
- •Pregnant or planning to become pregnant.
研究组 & 干预措施
REL-1017 25 mg
During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)
干预措施: REL-1017 (Drug)
Placebo
During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in MADRS Total Score From Baseline to Day 28
时间窗: Day 28
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.
Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline and Day 28
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score.
次要结局
- Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Baseline and Day 7)