DeliriumPhase 3NCT04571944
Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
A Phase 3 study testing Suvorexant in people with Delirium, run by Merck Sharp & Dohme LLC at 50 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Delirium
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 50 sitesJapan
- Study dates
- 22 Oct 2020to 23 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Japan50 sites
Kansai Rosai Hospital ( Site 8550)
Amagasaki, Hyōgo, 660-8511
National Hospital Organization Kyushu Medical Center ( Site 8532)
Fukuoka, 810-8563
Fukuyama City Hospital ( Site 8528)
Fukuyama, Hiroshima, 721-8511
Gifu Municipal Hospital ( Site 8555)
Gifu, 500-8513
Hiroshima City Hiroshima Citizens Hospital ( Site 8505)
Hiroshima, 730-8518
Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522)
Ichikawa, Chiba, 272-8516
Iizuka Hospital ( Site 8540)
Iizuka, Fukuoka
Shimane Prefectural Central Hospital ( Site 8530)
Izumo, Shimane, 693-8555
Kanazawa Medical University Hospital ( Site 8514)
Kahoku-gun, Ishikawa-ken, 920-0293
National Hospital Organization Kanazawa Medical Center ( Site 8554)
Kanazawa, Ishikawa-ken, 920-8650
Kamitsuga General Hospital ( Site 8546)
Kanuma, Tochigi, 322-8550
Nippon Medical School Musashi Kosugi Hospital ( Site 8502)
Kawasaki, Kanagawa, 211-8533
Kagawa University Hospital ( Site 8519)
Kita-gun, Kagawa-ken, 761-0793
Kokura Memorial Hospital ( Site 8537)
Kitakyushu, Fukuoka, 802-8555
National Hospital Organization Kumamoto Medical Center ( Site 8511)
Kumamoto, 860-0008
Japanese Red Cross Kyoto Daini Hospital ( Site 8533)
Kyoto, 602-8026
Kyoto Katsura Hospital ( Site 8539)
Kyoto, 615-8256
Maebashi Red Cross Hospital ( Site 8548)
Maebashi, Gunma, 371-0811
National Hospital Organization Maizuru Medical Center ( Site 8535)
Maizuru-shi, Kyoto, 625-8502
Aizawa Hospital ( Site 8542)
Matsumoto, Nagano, 390-8510
Miyazaki Prefectural Miyazaki Hospital ( Site 8543)
Miyazaki, 880-8510
Matsushita Memorial Hospital ( Site 8556)
Moriguchi, Osaka, 570-8540
Niigata City General Hospital ( Site 8544)
Niigata, 950-1197
Okayama Saiseikai General Hospital ( Site 8549)
Okayama, 700-8511
Okayama University Hospital ( Site 8510)
Okayama, 7008558
Osaka City General Hospital ( Site 8518)
Osaka, 534-0021
National Hospital Organization Osaka National Hospital ( Site 8536)
Osaka, 540-0006
Japanese Red Cross Osaka Hospital ( Site 8523)
Osaka, 543-8555
Nippon Life Hospital ( Site 8552)
Osaka, 550-0006
Japan Community Health care Organization Osaka Hospital ( Site 8545)
Osaka, 553-0003
Osaka General Medical Center ( Site 8538)
Osaka, 558-8558
Saga-Ken Medical Centre Koseikan ( Site 8526)
Saga, 840-8571
SANO KOSEI GENERAL HOSPITAL ( Site 8551)
Sano, Tochigi, 327-8511
Tonan Hospital ( Site 8512)
Sapporo, Hokkaido, 060-0004
Jichi Medical University Hospital ( Site 8525)
Shimotsuke, Tochigi, 329-0498
Osaka University Hospital ( Site 8524)
Suita, Osaka, 565-0871
TAKAMATSU Red Cross Hospital ( Site 8547)
Takamatsu, Kagawa-ken, 760-0017
Tokushima Prefectural Central Hospital ( Site 8509)
Tokushima, 770-8539
National Cancer Center Hospital ( Site 8520)
Tokyo, 104-0045
National Hospital Organization Tokyo Medical Center ( Site 8529)
Tokyo, 152-8902
Tokyo Women's Medical University Hospital ( Site 8527)
Tokyo, 162-8666
Juntendo University Nerima Hospital ( Site 8501)
Tokyo, 177-8521
Tokyo Medical and Dental University Hospital ( Site 8503)
Tokyo
Toyonaka Municipal Hospital ( Site 8521)
Toyonaka, Osaka, 560-8565
Yamaguchi University Hospital ( Site 8517)
Ube, Yamaguchi, 755-8505
Showa University Northern Yokohama Hospital ( Site 8534)
Yokohama, Kanagawa, 224-8503
Yokohama City University Medical Center ( Site 8516)
Yokohama, Kanagawa, 232-0024
Saiseikai Yokohamashi Nanbu Hospital ( Site 8541)
Yokohama, Kanagawa, 234-8503
Yokohama City University Hospital ( Site 8515)
Yokohama, Kanagawa, 2360064
National Hospital Organization Yokohama Medical Center ( Site 8531)
Yokohama, Kanagawa, 245-8575
About this study
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
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
- Being tested
- Suvorexant, Placebo
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Also called MK-4305
Suvorexant administered at a dose of 15 mg QD via oral tablet
PlaceboDrug
Suvorexant-matching placebo administered QD via oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant | Experimental | Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days. Receives: Drug: Suvorexant |
| Placebo | Placebo comparator | Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to ~7 days
Secondary outcomes (2)
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.
Measured: Up to ~8 days
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.
Measured: Up to ~8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start22 Oct 2020
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571944
- Sponsor's protocol ID
- 4305-085
- Other IDs
- MK-4305-085, jRCT2031200149
- Status last verified
- Nov 2024
- First submitted
- 25 Sep 2020
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 39150711
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04571944
- Acronym / sponsor ID
- 4305-085
- Conditions
- Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suvorexant | Experimental | Drug: SuvorexantParticipants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive suvorexant-matching placebo orally QD for 5 to 7 days. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvorexantAlso: MK-4305Suvorexant administered at a dose of 15 mg QD via oral tablet | Drug | Suvorexant |
| PlaceboSuvorexant-matching placebo administered QD via oral tablet | Drug | Placebo |
Primary outcome
Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria
Time frame: 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 Experienced One or More Adverse Events (AEs)
Time frame: 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.
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: 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.
2 secondary outcomes
Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98)
Time frame: Up to ~8 days
Percentage of Participants With Delirium as Assessed by DRS-R-98
Time frame: Up to ~8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39150711Hatta 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.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suvorexant in people with Delirium, run by Merck Sharp & Dohme LLC at 50 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria (time frame: Up to ~8 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.