Clinical trial NCT04571944: Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Delirium
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-10-01
Enrollment: 207
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria
timeFrame: Up to ~8 days
measure: Number of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to ~21 days
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~7 days
Secondary outcomes:
measure: Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98)
timeFrame: Up to ~8 days
measure: Percentage of Participants With Delirium as Assessed by DRS-R-98
timeFrame: Up to ~8 days
Other outcomes:
Locations:
city: Ichikawa
country: Japan
facility: Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522)
state: Chiba
city: Iizuka
country: Japan
facility: Iizuka Hospital ( Site 8540)
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital ( Site 8537)
state: Fukuoka
city: Maebashi
country: Japan
facility: Maebashi Red Cross Hospital ( Site 8548)
state: Gunma
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital ( Site 8528)
state: Hiroshima
city: Sapporo
country: Japan
facility: Tonan Hospital ( Site 8512)
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital ( Site 8550)
state: Hyogo
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital ( Site 8514)
state: Ishikawa
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center ( Site 8554)
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 8519)
state: Kagawa
city: Takamatsu
country: Japan
facility: TAKAMATSU Red Cross Hospital ( Site 8547)
state: Kagawa
city: Kawasaki
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital ( Site 8502)
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital ( Site 8534)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 8516)
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 8515)
state: Kanagawa
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center ( Site 8531)
state: Kanagawa
city: Maizuru-shi
country: Japan
facility: National Hospital Organization Maizuru Medical Center ( Site 8535)
state: Kyoto
city: Matsumoto
country: Japan
facility: Aizawa Hospital ( Site 8542)
state: Nagano
city: Moriguchi
country: Japan
facility: Matsushita Memorial Hospital ( Site 8556)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 8524)
state: Osaka
city: Toyonaka
country: Japan
facility: Toyonaka Municipal Hospital ( Site 8521)
state: Osaka
city: Izumo
country: Japan
facility: Shimane Prefectural Central Hospital ( Site 8530)
state: Shimane
city: Kanuma
country: Japan
facility: Kamitsuga General Hospital ( Site 8546)
state: Tochigi
city: Sano
country: Japan
facility: SANO KOSEI GENERAL HOSPITAL ( Site 8551)
state: Tochigi
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital ( Site 8525)
state: Tochigi
city: Ube
country: Japan
facility: Yamaguchi University Hospital ( Site 8517)
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 8532)
city: Gifu
country: Japan
facility: Gifu Municipal Hospital ( Site 8555)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 8505)
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center ( Site 8511)
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital ( Site 8533)
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital ( Site 8539)
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital ( Site 8543)
city: Niigata
country: Japan
facility: Niigata City General Hospital ( Site 8544)
city: Okayama
country: Japan
facility: Okayama Saiseikai General Hospital ( Site 8549)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 8510)
city: Osaka
country: Japan
facility: Osaka City General Hospital ( Site 8518)
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital ( Site 8536)
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital ( Site 8523)
city: Osaka
country: Japan
facility: Nippon Life Hospital ( Site 8552)
city: Osaka
country: Japan
facility: Japan Community Health care Organization Osaka Hospital ( Site 8545)
city: Osaka
country: Japan
facility: Osaka General Medical Center ( Site 8538)
city: Saga
country: Japan
facility: Saga-Ken Medical Centre Koseikan ( Site 8526)
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital ( Site 8509)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 8520)
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo Medical Center ( Site 8529)
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital ( Site 8527)
city: Tokyo
country: Japan
facility: Juntendo University Nerima Hospital ( Site 8501)
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital ( Site 8503)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hatta K, Kishi Y, Wada K, Takeuchi T, Taira T, Uemura K, Ogawa A, Takahashi K, Sato A, Shirakawa M, Herring WJ, Arano I; Suvorexant 085 Study Group. Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2427691. doi: 10.1001/jamanetworkopen.2024.27691.