Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Delirium

Treatments

Drug: Suvorexant

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04571944

4305-085

MK-4305-085 (Other Identifier)

jRCT2031200149 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

207 patients

Sex

All

Ages

65 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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