Delirium Clinical Trial
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
| Verified date | December 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 207 |
| Est. completion date | December 23, 2022 |
| Est. primary completion date | December 23, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kansai Rosai Hospital ( Site 8550) | Amagasaki | Hyogo |
| Japan | National Hospital Organization Kyushu Medical Center ( Site 8532) | Fukuoka | |
| Japan | Fukuyama City Hospital ( Site 8528) | Fukuyama | Hiroshima |
| Japan | Gifu Municipal Hospital ( Site 8555) | Gifu | |
| Japan | Hiroshima City Hiroshima Citizens Hospital ( Site 8505) | Hiroshima | |
| Japan | Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522) | Ichikawa | Chiba |
| Japan | Iizuka Hospital ( Site 8540) | Iizuka | Fukuoka |
| Japan | Shimane Prefectural Central Hospital ( Site 8530) | Izumo | Shimane |
| Japan | Kanazawa Medical University Hospital ( Site 8514) | Kahoku-gun | Ishikawa |
| Japan | National Hospital Organization Kanazawa Medical Center ( Site 8554) | Kanazawa | Ishikawa |
| Japan | Kamitsuga General Hospital ( Site 8546) | Kanuma | Tochigi |
| Japan | Nippon Medical School Musashi Kosugi Hospital ( Site 8502) | Kawasaki | Kanagawa |
| Japan | Kagawa University Hospital ( Site 8519) | Kita-gun | Kagawa |
| Japan | Kokura Memorial Hospital ( Site 8537) | Kitakyushu | Fukuoka |
| 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 | Maebashi Red Cross Hospital ( Site 8548) | Maebashi | Gunma |
| Japan | National Hospital Organization Maizuru Medical Center ( Site 8535) | Maizuru-shi | Kyoto |
| Japan | Aizawa Hospital ( Site 8542) | Matsumoto | Nagano |
| Japan | Miyazaki Prefectural Miyazaki Hospital ( Site 8543) | Miyazaki | |
| Japan | Matsushita Memorial Hospital ( Site 8556) | Moriguchi | Osaka |
| Japan | Niigata City General Hospital ( Site 8544) | Niigata | |
| Japan | Okayama Saiseikai General Hospital ( Site 8549) | Okayama | |
| Japan | Okayama University Hospital ( Site 8510) | Okayama | |
| Japan | Japan Community Health care Organization Osaka Hospital ( Site 8545) | Osaka | |
| Japan | Japanese Red Cross Osaka Hospital ( Site 8523) | Osaka | |
| Japan | National Hospital Organization Osaka National Hospital ( Site 8536) | Osaka | |
| Japan | Nippon Life Hospital ( Site 8552) | Osaka | |
| Japan | Osaka City General Hospital ( Site 8518) | Osaka | |
| Japan | Osaka General Medical Center ( Site 8538) | Osaka | |
| Japan | Saga-Ken Medical Centre Koseikan ( Site 8526) | Saga | |
| Japan | SANO KOSEI GENERAL HOSPITAL ( Site 8551) | Sano | Tochigi |
| Japan | Tonan Hospital ( Site 8512) | Sapporo | Hokkaido |
| Japan | Jichi Medical University Hospital ( Site 8525) | Shimotsuke | Tochigi |
| Japan | Osaka University Hospital ( Site 8524) | Suita | Osaka |
| Japan | TAKAMATSU Red Cross Hospital ( Site 8547) | Takamatsu | Kagawa |
| Japan | Tokushima Prefectural Central Hospital ( Site 8509) | Tokushima | |
| Japan | Juntendo University Nerima Hospital ( Site 8501) | Tokyo | |
| Japan | National Cancer Center Hospital ( Site 8520) | Tokyo | |
| Japan | National Hospital Organization Tokyo Medical Center ( Site 8529) | Tokyo | |
| Japan | Tokyo Medical and Dental University Hospital ( Site 8503) | Tokyo | |
| Japan | Tokyo Women's Medical University Hospital ( Site 8527) | Tokyo | |
| Japan | Toyonaka Municipal Hospital ( Site 8521) | Toyonaka | Osaka |
| Japan | Yamaguchi University Hospital ( Site 8517) | Ube | Yamaguchi |
| Japan | National Hospital Organization Yokohama Medical Center ( Site 8531) | Yokohama | Kanagawa |
| Japan | Saiseikai Yokohamashi Nanbu Hospital ( Site 8541) | Yokohama | Kanagawa |
| Japan | Showa University Northern Yokohama Hospital ( Site 8534) | Yokohama | Kanagawa |
| Japan | Yokohama City University Hospital ( Site 8515) | Yokohama | Kanagawa |
| Japan | Yokohama City University Medical Center ( Site 8516) | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98) | 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. | Up to ~8 days | |
| Secondary | Percentage of Participants With Delirium as Assessed by DRS-R-98 | 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. | Up to ~8 days |
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