A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of MK-4305 (Suvorexant) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 50
- 主要终点
- Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria
研究概览
简要总结
The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for reducing the incidence of delirium in Japanese participants who are at high risk of delirium. The primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is hospitalized for (1) acute disease with severe disease state or decreased daily living function or (2) elective surgery requiring general anesthesia scheduled on the day after or 2 days after admission/Day 1
- •Has (1) mild cognitive impairment or mild dementia and/or (2) a history of delirium in any prior hospitalization
- •Requires hospitalization for 6 days for acute disease, with treatment starting on day of admission; or 7 days, with treatment starting the day after admission OR
- •Requires hospitalization for 6 days for elective surgery scheduled on the day after admission; or for 7 days for elective surgery scheduled 2 days after admission
- •Is able to take study medications orally
排除标准
- •Has moderate or severe dementia
- •Has a history of epilepsy or Parkinson's disease
- •Currently uses psychotropic agents or has a mental condition including schizophrenia, other mental disorders, bipolar disorder and major depression
- •Has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease such as alcoholic liver disease or gastritis alcoholic
- •Has a history of narcolepsy or cataplexy
- •Has used hypnotics, antipsychotics, mood stabilizers, antidepressants, anxiolytics, psychostimulants, anticonvulsants or tiapride within 2 weeks prior to randomization
- •Has delirium as assessed by DSM-5 or DRS-R-98 (total score ≥14.5) before the first dose of study medication
研究组 & 干预措施
Suvorexant
Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
干预措施: Suvorexant (Drug)
Placebo
Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria
时间窗: Up to ~8 days
The DSM-5 is the gold standard for the diagnosis of delirium. DSM-5 criteria were used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria is presented.
Number of Participants Who Discontinued Study Treatment Due to an AE
时间窗: Up to ~7 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented.
Number of Participants Who Experienced One or More Adverse Events (AEs)
时间窗: Up to ~21 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs is presented.
次要结局
- Percentage of Participants With Delirium as Assessed by DRS-R-98(Up to ~8 days)
- Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98)(Up to ~8 days)