A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,304
- 试验地点
- 131
- 主要终点
- Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).
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
- Triple (Participant, 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 Screening
- •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 Screening
- •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 Every 2 Weeks
Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
干预措施: Rapastinel (Drug)
Rapastinel 450 mg Weekly
Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
干预措施: Rapastinel (Drug)
Placebo
Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
干预措施: Placebo-matching Rapastinel (Drug)
结局指标
主要结局
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
时间窗: 52 Weeks
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
时间窗: 104 Weeks
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
次要结局
- Time to First Relapse During the Entire Double-Blind Treatment Period(104 Weeks)