NCT07772531尚未招募2 期
A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of BMS-986511 in Two Sequential Parts in Participants With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 28
- 主要终点
- Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score
研究概览
简要总结
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview.
- •Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale.
- •Participant must have current MDE duration >12 weeks at screening.
- •Outpatient participants able to comply with study procedures.
- •Participant require medication washout completed before baseline.
- •Participant must have BMI within protocol range.
- •Participants must meet reproductive safety requirements.
排除标准
- •Participants must not have other primary psychiatric disorders or a history of treatment-resistant depression during the current episode.
- •Participants must not have recent history of active suicidal ideation or attempt within the past year.
- •Participants must not have prior lifetime treatment with electroconvulsive therapy, ketamine/esketamine, deep brain stimulation, or transcranial magnetic stimulation.
- •Participants must not have recent history of alcohol/substance abuse or use of cannabis.
- •Participants must not have significant ECG abnormalities, or poorly controlled diabetes.
- •Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986511: Dose A
Experimental
干预措施: BMS-986511 (Drug)
BMS-986511: Dose B
Experimental
干预措施: BMS-986511 (Drug)
Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score
时间窗: Up to Day 57
次要结局
- Number of Participants with Treatment Emergent Adverse Events (AEs)(Up to 71 days)
- Number of Participants with Serious Adverse Events (SAEs)(Up to 71 days)
- Number of Participants with AEs Leading to Treatment Discontinuation(Up to 71 days)
- Number of Participants with AEs Leading to Death(Up to Day 71)
研究者
研究点 (28)
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