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

Tanaka Yoshiyuki0 个研究点目标入组 200 人开始时间: 2020年10月13日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 (1) for 6 days for acute disease with treatment starting on the day of admission, or 7 days for acute disease with treatment starting the day after admission, OR (2) for 6 days for elective surgery scheduled the day after admission, or for 7 days for elective surgery scheduled 2 days after admission
•- Is able to take study medications orally

•- Has moderate or severe dementia
•- Has a history of epilepsy or Parkinson's disease
•- Currently uses psychotropic agents or has a mental condition
•- Has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease
•- 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

发起方

Tanaka Yoshiyuki