A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 429
- 试验地点
- 40
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
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
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
- •Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
- •Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
- •If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
排除标准
- •DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
- •Lifetime history of meeting DSM-5 criteria for:
- •Schizophrenia spectrum or other psychotic disorder
- •Bipolar or related disorder
- •Major neurocognitive disorder
- •Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
- •Dissociative disorder
- •Posttraumatic stress disorder
- •MDD with psychotic features
- •Significant suicide risk, as judged by the Investigator.
研究组 & 干预措施
Rapastinel 450 mg
Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
干预措施: Rapastinel (Drug)
Placebo
Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
时间窗: Baseline and 3 Weeks
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
次要结局
- Change From Baseline in MADRS Total Score(Baseline and Day 8)
- Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population(Baseline and Day 8)
- Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population(Baseline and Day 21)