A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 138
- 试验地点
- 17
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.
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 4 weeks and not exceeding 24 months in duration at visit 1
- •Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
- •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 1 month before Visit
- •Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
- •Prior participation in any investigational study of rapastinel/GLYX-13
研究组 & 干预措施
Rapastinel 450mg
Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
干预措施: Rapastinel (Drug)
Placebo
Placebo-matching rapastinel weekly IV injections.
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
时间窗: Baseline and 1 Day
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 a 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.
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
时间窗: Baseline and 1 Day
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
次要结局
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline and 28 Days)
- Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score(Baseline and 28 Days)