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

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.

Timeline

Start

2020-10-22

Primary completion

2022-12-23

Completion

2022-12-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Suvorexant vs Placebo; p = 0.129; Difference in % vs Placebo -8.7 (95% CI -20.1 to 2.6); Miettinen and Nurminen method NCT04571944 ↗

paper fewer participants taking suvorexant had delirium compared with placebo, but the difference was not statistically significant. PMID 39150711 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Suvorexant	Small molecule	15 mg	Oral

Indications