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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
207
Suvorexant administered at a dose of 15 mg QD via oral tablet
Suvorexant-matching placebo administered QD via oral tablet
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to ~7 days
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.
Time frame: 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.
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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
...and 40 more locations
Time frame: Up to ~8 days