Preventive Effects of Suvorexant on Delirium: A Randomized Placebo-Controlled Trial
| Autor: | Ken Wada, Hiroyuki Nakamura, Chie Usui, Shigeo Ito, Akiko Kurata, Manabu Sugita, Yasuhiro Kishi, Kotaro Hatta, Kazunori Murakami, Takashi Takeuchi |
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| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Placebo-controlled study Placebo behavioral disciplines and activities law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Intensive care Internal medicine Acute care mental disorders Medicine Humans 030212 general & internal medicine Psychiatry Aged Aged 80 and over Psychiatric Status Rating Scales business.industry Suvorexant Delirium Azepines Triazoles Clinical trial Diagnostic and Statistical Manual of Mental Disorders Psychiatry and Mental health Intensive Care Units Treatment Outcome Female Orexin Receptor Antagonists medicine.symptom Drug Monitoring business 030217 neurology & neurosurgery |
| Zdroj: | The Journal of clinical psychiatry. 78(8) |
| ISSN: | 1555-2101 |
| Popis: | Objective No highly effective pharmacologic interventions to prevent delirium have been identified. We examined whether suvorexant, a potent and selective orexin receptor antagonist, is effective for the prevention of delirium. Methods We conducted a multicenter, rater-blinded, randomized, placebo-controlled clinical trial in intensive care units and regular acute wards between April 2015 and March 2016. Eligible patients were 65 to 89 years old, newly admitted due to emergency, and able to take medicine orally and had an expected stay or life expectancy of 48 hours or more. Seventy-two patients were randomly assigned using the sealed envelope method to receive suvorexant (15 mg/d; 36 patients) or placebo (36 patients) every night for 3 days. The primary outcome measure was incidence of delirium as determined by the DSM-5. Trained psychiatrists assessed for delirium. Results We found that delirium developed significantly less often among patients taking suvorexant than among those taking placebo (0% [n/N = 0/36] vs 17% [6/36], respectively, P = .025). Comparison by log-rank test also showed that delirium developed significantly less often among patients taking suvorexant than among those taking placebo (χ² = 6.46, P = .011). Analysis of variance revealed a tendency for main effect of treatment (F = 3.79, P = .053) on the sleep-wake cycle disturbance score (item 1) of the Japanese version of the Delirium Rating Scale-Revised-98 (DRS-R-98-J). There were no significant differences in adverse events. Conclusions Suvorexant administered nightly to elderly patients admitted for acute care may provide protection against delirium. Larger studies are needed to show the potential of suvorexant to improve the circadian core domain of delirium. Trial registration UMIN Clinical Trials Registry identifier: UMIN000015681. |
| Databáze: | OpenAIRE |
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