A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 363
- 试验地点
- 52
- 主要终点
- Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
研究概览
简要总结
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
- •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:
- •1.Schizophrenia spectrum or other psychotic disorder
- •2.Bipolar or related disorder
- •3.Major neurocognitive disorder
- •4.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
- •5.Dissociative disorder
- •6.Posttraumatic stress disorder
- •7.MDD with psychotic features
- •Significant suicide risk, as judged by the Investigator
研究组 & 干预措施
Rapastinel weekly
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
干预措施: Rapastinel (Drug)
Rapastinel clinically driven schedule
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
干预措施: Rapastinel (Drug)
Placebo weekly
Placebo (prefilled syringe, weekly IV administration)
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
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.
次要结局
未报告次要终点