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

NCT04571944 | Completed Phase 3 Results

• 3 other identifiers: 4305-085MK-4305-085jRCT2031200149
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 50

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (3)

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

  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.

  Up to ~8 days

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

  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.

  Up to ~21 days

• Number of Participants Who Discontinued Study Treatment Due to an AE

  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.

  Up to ~7 days

Secondary Outcomes (2)

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

  Up to ~8 days

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

  Up to ~8 days

Study Arms (2)

Suvorexant

EXPERIMENTAL

Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days.

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days.

Drug: Placebo

Interventions

Suvorexant DRUG

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

Also known as: MK-4305

Suvorexant

Placebo DRUG

Suvorexant-matching placebo administered QD via oral tablet

Placebo

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (50)

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

Ichikawa, Chiba, 272-8516, Japan

Location

Iizuka Hospital ( Site 8540)

Iizuka, Fukuoka, Japan

Location

Kokura Memorial Hospital ( Site 8537)

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Maebashi Red Cross Hospital ( Site 8548)

Maebashi, Gunma, 371-0811, Japan

Location

Fukuyama City Hospital ( Site 8528)

Fukuyama, Hiroshima, 721-8511, Japan

Location

Tonan Hospital ( Site 8512)

Sapporo, Hokkaido, 060-0004, Japan

Location

Kansai Rosai Hospital ( Site 8550)

Amagasaki, Hyōgo, 660-8511, Japan

Location

Kanazawa Medical University Hospital ( Site 8514)

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

National Hospital Organization Kanazawa Medical Center ( Site 8554)

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Kagawa University Hospital ( Site 8519)

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

TAKAMATSU Red Cross Hospital ( Site 8547)

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Nippon Medical School Musashi Kosugi Hospital ( Site 8502)

Kawasaki, Kanagawa, 211-8533, Japan

Location

Showa University Northern Yokohama Hospital ( Site 8534)

Yokohama, Kanagawa, 224-8503, Japan

Location

Yokohama City University Medical Center ( Site 8516)

Yokohama, Kanagawa, 232-0024, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)

Yokohama, Kanagawa, 234-8503, Japan

Location

Yokohama City University Hospital ( Site 8515)

Yokohama, Kanagawa, 2360064, Japan

Location

National Hospital Organization Yokohama Medical Center ( Site 8531)

Yokohama, Kanagawa, 245-8575, Japan

Location

National Hospital Organization Maizuru Medical Center ( Site 8535)

Maizuru-shi, Kyoto, 625-8502, Japan

Location

Aizawa Hospital ( Site 8542)

Matsumoto, Nagano, 390-8510, Japan

Location

Matsushita Memorial Hospital ( Site 8556)

Moriguchi, Osaka, 570-8540, Japan

Location

Osaka University Hospital ( Site 8524)

Suita, Osaka, 565-0871, Japan

Location

Toyonaka Municipal Hospital ( Site 8521)

Toyonaka, Osaka, 560-8565, Japan

Location

Shimane Prefectural Central Hospital ( Site 8530)

Izumo, Shimane, 693-8555, Japan

Location

Kamitsuga General Hospital ( Site 8546)

Kanuma, Tochigi, 322-8550, Japan

Location

SANO KOSEI GENERAL HOSPITAL ( Site 8551)

Sano, Tochigi, 327-8511, Japan

Location

Jichi Medical University Hospital ( Site 8525)

Shimotsuke, Tochigi, 329-0498, Japan

Location

Yamaguchi University Hospital ( Site 8517)

Ube, Yamaguchi, 755-8505, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 8532)

Fukuoka, 810-8563, Japan

Location

Gifu Municipal Hospital ( Site 8555)

Gifu, 500-8513, Japan

Location

Hiroshima City Hiroshima Citizens Hospital ( Site 8505)

Hiroshima, 730-8518, Japan

Location

National Hospital Organization Kumamoto Medical Center ( Site 8511)

Kumamoto, 860-0008, Japan

Location

Japanese Red Cross Kyoto Daini Hospital ( Site 8533)

Kyoto, 602-8026, Japan

Location

Kyoto Katsura Hospital ( Site 8539)

Kyoto, 615-8256, Japan

Location

Miyazaki Prefectural Miyazaki Hospital ( Site 8543)

Miyazaki, 880-8510, Japan

Location

Niigata City General Hospital ( Site 8544)

Niigata, 950-1197, Japan

Location

Okayama Saiseikai General Hospital ( Site 8549)

Okayama, 700-8511, Japan

Location

Okayama University Hospital ( Site 8510)

Okayama, 7008558, Japan

Location

Osaka City General Hospital ( Site 8518)

Osaka, 534-0021, Japan

Location

National Hospital Organization Osaka National Hospital ( Site 8536)

Osaka, 540-0006, Japan

Location

Japanese Red Cross Osaka Hospital ( Site 8523)

Osaka, 543-8555, Japan

Location

Nippon Life Hospital ( Site 8552)

Osaka, 550-0006, Japan

Location

Japan Community Health care Organization Osaka Hospital ( Site 8545)

Osaka, 553-0003, Japan

Location

Osaka General Medical Center ( Site 8538)

Osaka, 558-8558, Japan

Location

Saga-Ken Medical Centre Koseikan ( Site 8526)

Saga, 840-8571, Japan

Location

Tokushima Prefectural Central Hospital ( Site 8509)

Tokushima, 770-8539, Japan

Location

National Cancer Center Hospital ( Site 8520)

Tokyo, 104-0045, Japan

Location

National Hospital Organization Tokyo Medical Center ( Site 8529)

Tokyo, 152-8902, Japan

Location

Tokyo Women's Medical University Hospital ( Site 8527)

Tokyo, 162-8666, Japan

Location

Juntendo University Nerima Hospital ( Site 8501)

Tokyo, 177-8521, Japan

Location

Tokyo Medical and Dental University Hospital ( Site 8503)

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 39150711 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Delirium

Interventions

suvorexant

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: October 22, 2020
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: November 25, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (50)