2015 Fiscal Year Research-status Report
神経炎症を視点にしたせん妄の予測，予防，治療に関する総合研究
| Project/Area Number |
26461773
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| Research Institution | Juntendo University |
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Principal Investigator |
八田 耕太郎 順天堂大学, 医学部, 准教授 (90337915)
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| Co-Investigator(Kenkyū-buntansha) |
岸 泰宏 日本医科大学, 医学部, 准教授 (60256930)
竹内 崇 東京医科歯科大学, 医学部附属病院, 講師 (70345289)
小田原 俊成 横浜市立大学, 保健管理センター, 教授 (00244426)
杉田 学 順天堂大学, 医学部, 准教授 (20322414)
町田 裕 順天堂大学, 医学部, 准教授 (90317470) [Withdrawn]
野田 隆政 国立研究開発法人国立精神・神経医療研究センター, その他部局等, その他 (50446572)
臼井 千恵 順天堂大学, 医学部, 准教授 (70453587)
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Keywords | delirium / suvorexant / prevention / clinical trial |
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| Outline of Annual Research Achievements |
Backround: Highly effective interventions to prevent delirium have been explored. Suvorexant, a potent and selective orexin receptor antagonist, can be effective for insomnia even in patients with high risk of delirium due to the completely different mechanism of promoting sleep from previous drugs. We examined whether suvorexant is effective for the prevention of delirium.
Methods: In this multi-center, rater-blinded, randomized placebo-controlled clinical trial, patients with 65-89 years old, newly admitted to intensive care units and regular acute wards due to emergency, and able to take medicine orally were assigned to receive suvorexant (15 mg/day; n=36) and placebo (n=36) every night for four days. Main Outcome Measure was incidence of delirium as determined by the DSM-5.
Findings: There was significant difference in the rate of developing delirium between the suvorexant group and the placebo group (0% vs. 17%, P=0.025). Comparison by log-rank test showed that development of delirium occurred significantly less often among patients taking suvorexant than among those taking placebo (χ2=6.46, P=0.011). There were no significant differences in adverse events and any items of sleep metrics between groups.
Interpretation: Suvorexant administered nightly to elderly patients admitted for acute care may provide protection against delirium. The preventive effects of suvorexant on delirium can be different from sleep promoting effects, and the results raise a possibility of association between orexin neurotransmission and etiologies of delirium.
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| Current Status of Research Progress |
Current Status of Research Progress
2: Research has progressed on the whole more than it was originally planned.
Reason
A randomized clinical trial of suvorexant on delirium prevention has been completed, as I had expected.
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| Strategy for Future Research Activity |
One limitation of this study was the relatively small sample size, although the number of participants was above the required number as set by power analysis. Another limitation was the single-blind design. To the best of our knowledge, this represents the first study about preventive effects of suvorexant on delirium. Further work with a larger number of patients and a longer period of observation, and targeting population with higher risk of delirium such as CDR =>0.5 is needed.
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| Causes of Carryover |
平成28年3月に測定した検査費用の請求が翌月（新年度4月）になるため
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| Expenditure Plan for Carryover Budget |
上記の検査費用の請求額がわかる平成28年4月に使用する。
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Research Products
(12 results)
