Phase 3
N=207
Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
Delirium
Bottom Line
View on ClinicalTrials.gov: NCT04571944 ↗Enrolled (actual)
207
Serious AEs
5.9%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria — 16.8; 26.5 Percentage of participants — p=0.129
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Suvorexant (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria |
16.8; 26.5 | 0.129 |
| PRIMARY Number of Participants Who Experienced One or More Adverse Events (AEs) |
86; 86 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an AE |
2; 2 | — |
| SECONDARY Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98) |
7.0; 7.5 | 0.485 |
| SECONDARY Percentage of Participants With Delirium as Assessed by DRS-R-98 |
17.8; 26.5 | 0.136 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04571944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.