A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-II Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 236
- 试验地点
- 71
- 主要终点
- Change in the MADRS10 total score
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 an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the 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.
- •Current Major Depressive Episode (MDE).
- •Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.
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.
- •Poorly controlled diabetes as defined by HbA1c > 7.5%, despite standard care. Subjects with HbA1c >7.5% may continue in the study if approved by the Relmada Medical Monitor.
- •Having received ketamine or esketamine within 60 days prior to Screening.
研究组 & 干预措施
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)
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)
结局指标
主要结局
Change in the MADRS10 total score
时间窗: Day 28
Therapeutic efficacy of REL-1017 as adjunctive treatment 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. A negative change from baseline indicates improvement.
Change From Baseline to Day 28 in 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 in CGI-S score(Day 28)
- Change in the MADRS10 total score(Day 7)
- MADRS10 Response Rater(Day 28)
- MADRS10 Remission Rate(Day 28)
- Change From Baseline to Day 7 in MADRS Total Score(Day 7)
- Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score(Day 28)
- MADRS10 Remission Rate at Day 28(Day 28)
- MADRS10 Response Rate at Day 28(Day 28)