Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
NCT ID: NCT04571944
Last Updated: 2024-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2020-10-22
2022-12-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
NCT07033494
A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)
NCT05466422
Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
NCT00359944
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
NCT03740178
Safety and Efficacy of MT-4666
NCT01764243
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Suvorexant
Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.
Suvorexant
Suvorexant administered at a dose of 15 mg QD via oral tablet
Placebo
Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.
Placebo
Suvorexant-matching placebo administered QD via oral tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Suvorexant
Suvorexant administered at a dose of 15 mg QD via oral tablet
Placebo
Suvorexant-matching placebo administered QD via oral tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
65 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522)
Ichikawa, Chiba, Japan
Iizuka Hospital ( Site 8540)
Iizuka, Fukuoka, Japan
Kokura Memorial Hospital ( Site 8537)
Kitakyushu, Fukuoka, Japan
Maebashi Red Cross Hospital ( Site 8548)
Maebashi, Gunma, Japan
Fukuyama City Hospital ( Site 8528)
Fukuyama, Hiroshima, Japan
Tonan Hospital ( Site 8512)
Sapporo, Hokkaido, Japan
Kansai Rosai Hospital ( Site 8550)
Amagasaki, Hyōgo, Japan
Kanazawa Medical University Hospital ( Site 8514)
Kahoku-gun, Ishikawa-ken, Japan
National Hospital Organization Kanazawa Medical Center ( Site 8554)
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital ( Site 8519)
Kita-gun, Kagawa-ken, Japan
TAKAMATSU Red Cross Hospital ( Site 8547)
Takamatsu, Kagawa-ken, Japan
Nippon Medical School Musashi Kosugi Hospital ( Site 8502)
Kawasaki, Kanagawa, Japan
Showa University Northern Yokohama Hospital ( Site 8534)
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center ( Site 8516)
Yokohama, Kanagawa, Japan
Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)
Yokohama, Kanagawa, Japan
Yokohama City University Hospital ( Site 8515)
Yokohama, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center ( Site 8531)
Yokohama, Kanagawa, Japan
National Hospital Organization Maizuru Medical Center ( Site 8535)
Maizuru-shi, Kyoto, Japan
Aizawa Hospital ( Site 8542)
Matsumoto, Nagano, Japan
Matsushita Memorial Hospital ( Site 8556)
Moriguchi, Osaka, Japan
Osaka University Hospital ( Site 8524)
Suita, Osaka, Japan
Toyonaka Municipal Hospital ( Site 8521)
Toyonaka, Osaka, Japan
Shimane Prefectural Central Hospital ( Site 8530)
Izumo, Shimane, Japan
Kamitsuga General Hospital ( Site 8546)
Kanuma, Tochigi, Japan
SANO KOSEI GENERAL HOSPITAL ( Site 8551)
Sano, Tochigi, Japan
Jichi Medical University Hospital ( Site 8525)
Shimotsuke, Tochigi, Japan
Yamaguchi University Hospital ( Site 8517)
Ube, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center ( Site 8532)
Fukuoka, , Japan
Gifu Municipal Hospital ( Site 8555)
Gifu, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 8505)
Hiroshima, , Japan
National Hospital Organization Kumamoto Medical Center ( Site 8511)
Kumamoto, , Japan
Japanese Red Cross Kyoto Daini Hospital ( Site 8533)
Kyoto, , Japan
Kyoto Katsura Hospital ( Site 8539)
Kyoto, , Japan
Miyazaki Prefectural Miyazaki Hospital ( Site 8543)
Miyazaki, , Japan
Niigata City General Hospital ( Site 8544)
Niigata, , Japan
Okayama Saiseikai General Hospital ( Site 8549)
Okayama, , 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
Japanese Red Cross Osaka Hospital ( Site 8523)
Osaka, , Japan
Nippon Life Hospital ( Site 8552)
Osaka, , Japan
Japan Community Health care Organization Osaka Hospital ( Site 8545)
Osaka, , Japan
Osaka General Medical Center ( Site 8538)
Osaka, , Japan
Saga-Ken Medical Centre Koseikan ( Site 8526)
Saga, , Japan
Tokushima Prefectural Central Hospital ( Site 8509)
Tokushima, , Japan
National Cancer Center Hospital ( Site 8520)
Tokyo, , Japan
National Hospital Organization Tokyo Medical Center ( Site 8529)
Tokyo, , Japan
Tokyo Women's Medical University Hospital ( Site 8527)
Tokyo, , Japan
Juntendo University Nerima Hospital ( Site 8501)
Tokyo, , Japan
Tokyo Medical and Dental University Hospital ( Site 8503)
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-4305-085
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031200149
Identifier Type: REGISTRY
Identifier Source: secondary_id
4305-085
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.