Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
- Registration Number
- NCT04571944
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days. Suvorexant Suvorexant Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria 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.
Number of Participants Who Discontinued Study Treatment Due to an AE 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.
Number of Participants Who Experienced One or More Adverse Events (AEs) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Delirium as Assessed by DRS-R-98 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.
Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98) 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.
Trial Locations
- Locations (50)
Kanazawa Medical University Hospital ( Site 8514)
🇯🇵Kahoku-gun, Ishikawa, Japan
Nippon Medical School Musashi Kosugi Hospital ( Site 8502)
🇯🇵Kawasaki, Kanagawa, Japan
Tonan Hospital ( Site 8512)
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Maizuru Medical Center ( Site 8535)
🇯🇵Maizuru-shi, Kyoto, Japan
Niigata City General Hospital ( Site 8544)
🇯🇵Niigata, Japan
Nippon Life Hospital ( Site 8552)
🇯🇵Osaka, Japan
National Hospital Organization Tokyo Medical Center ( Site 8529)
🇯🇵Tokyo, Japan
Tokyo Women's Medical University Hospital ( Site 8527)
🇯🇵Tokyo, Japan
Maebashi Red Cross Hospital ( Site 8548)
🇯🇵Maebashi, Gunma, Japan
Fukuyama City Hospital ( Site 8528)
🇯🇵Fukuyama, Hiroshima, Japan
Kansai Rosai Hospital ( Site 8550)
🇯🇵Amagasaki, Hyogo, Japan
Kagawa University Hospital ( Site 8519)
🇯🇵Kita-gun, Kagawa, Japan
Kamitsuga General Hospital ( Site 8546)
🇯🇵Kanuma, Tochigi, Japan
Jichi Medical University Hospital ( Site 8525)
🇯🇵Shimotsuke, Tochigi, Japan
National Hospital Organization Kumamoto Medical Center ( Site 8511)
🇯🇵Kumamoto, Japan
Okayama University Hospital ( Site 8510)
🇯🇵Okayama, Japan
Osaka City General Hospital ( Site 8518)
🇯🇵Osaka, Japan
National Hospital Organization Osaka National Hospital ( Site 8536)
🇯🇵Osaka, Japan
Osaka General Medical Center ( Site 8538)
🇯🇵Osaka, Japan
Tokushima Prefectural Central Hospital ( Site 8509)
🇯🇵Tokushima, Japan
National Cancer Center Hospital ( Site 8520)
🇯🇵Tokyo, Japan
Kyoto Katsura Hospital ( Site 8539)
🇯🇵Kyoto, Japan
Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)
🇯🇵Yokohama, Kanagawa, Japan
Miyazaki Prefectural Miyazaki Hospital ( Site 8543)
🇯🇵Miyazaki, Japan
Okayama Saiseikai General Hospital ( Site 8549)
🇯🇵Okayama, Japan
Tokyo Medical and Dental University Hospital ( Site 8503)
🇯🇵Tokyo, Japan
Iizuka Hospital ( Site 8540)
🇯🇵Iizuka, Fukuoka, Japan
Showa University Northern Yokohama Hospital ( Site 8534)
🇯🇵Yokohama, Kanagawa, Japan
Yokohama City University Hospital ( Site 8515)
🇯🇵Yokohama, Kanagawa, Japan
Toyonaka Municipal Hospital ( Site 8521)
🇯🇵Toyonaka, Osaka, Japan
Gifu Municipal Hospital ( Site 8555)
🇯🇵Gifu, Japan
Juntendo University Nerima Hospital ( Site 8501)
🇯🇵Tokyo, Japan
Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522)
🇯🇵Ichikawa, Chiba, Japan
Yokohama City University Medical Center ( Site 8516)
🇯🇵Yokohama, Kanagawa, Japan
Aizawa Hospital ( Site 8542)
🇯🇵Matsumoto, Nagano, Japan
Matsushita Memorial Hospital ( Site 8556)
🇯🇵Moriguchi, Osaka, Japan
Yamaguchi University Hospital ( Site 8517)
🇯🇵Ube, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center ( Site 8532)
🇯🇵Fukuoka, Japan
National Hospital Organization Kanazawa Medical Center ( Site 8554)
🇯🇵Kanazawa, Ishikawa, Japan
Osaka University Hospital ( Site 8524)
🇯🇵Suita, Osaka, Japan
SANO KOSEI GENERAL HOSPITAL ( Site 8551)
🇯🇵Sano, Tochigi, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 8505)
🇯🇵Hiroshima, Japan
Japanese Red Cross Kyoto Daini Hospital ( Site 8533)
🇯🇵Kyoto, Japan
Saga-Ken Medical Centre Koseikan ( Site 8526)
🇯🇵Saga, Japan
Kokura Memorial Hospital ( Site 8537)
🇯🇵Kitakyushu, Fukuoka, Japan
TAKAMATSU Red Cross Hospital ( Site 8547)
🇯🇵Takamatsu, Kagawa, Japan
National Hospital Organization Yokohama Medical Center ( Site 8531)
🇯🇵Yokohama, Kanagawa, Japan
Shimane Prefectural Central Hospital ( Site 8530)
🇯🇵Izumo, Shimane, Japan
Japanese Red Cross Osaka Hospital ( Site 8523)
🇯🇵Osaka, Japan
Japan Community Health care Organization Osaka Hospital ( Site 8545)
🇯🇵Osaka, Japan