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Completed

NCT Number: NCT04571944

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

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522), Ichikawa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suvorexant

Drug

Suvorexant administered at a dose of 15 mg QD via oral tablet

Other names: MK-4305

Placebo

Drug

Suvorexant-matching placebo administered QD via oral tablet

Primary outcomes

  1. Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria

    Time frame: 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.

  2. Number of Participants Who Experienced One or More Adverse Events (AEs)

    Time frame: 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.

  3. Number of Participants Who Discontinued Study Treatment Due to an AE

    Time frame: 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.

Secondary outcomes

  1. Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98)

    Time frame: Up to ~8 days

    DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. The maximum daily total score on DRS-R-98 is presented.

  2. Percentage of Participants With Delirium as Assessed by DRS-R-98

    Time frame: Up to ~8 days

    DRS-R-98 is a diagnostic and assessment tool used for the evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. Optimized cutoff score for delirium diagnosis in Japanese-translated DRS-R-98 has been determined as ≥14.5. The percentage of participants with delirium as assessed by DRS-R-98, defined as the percentage of participants with total score ≥14.5 per DRS-R-98, is presented.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2020
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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