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

• Status: Recruiting
• Trial end date: 2022-03-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Suvorexant

Criteria

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