Prediction and prevention of delirium

Not Applicable

• Conditions: delirium

• Registration Number: JPRN-UMIN000005591
• Lead Sponsor: Juntendo University Nerima Hospital

Brief Summary

Results: Ramelteon was associated with lower risk of delirium (3% vs. 32%, P=.003), with a relative risk of 0.09 (95% confidence interval (CI), 0.01-0.69). Even after controlling for risk factors, ramelteon was still associated with a lower incidence of delirium (P=.01; odds ratio, 0.07; 95%CI, 0.008-0.54). Kaplan-Meier estimates of time to development of delirium were 6.94 days (95%CI, 6.82-7.06 days) for ramelteon and 5.74 days (5.05-6.42 days) for placebo. Comparison by log-rank test showed that the frequency of developing delirium was significantly lower in patients taking ramelteon than in those taking placebo (X2=9.83, P=.002). Conclusions and Relevance: Ramelteon administered nightly to elderly patients admitted for acute care may provide protection against delirium. This finding supports a possible pathogenic role of melatonin neurotransmission in delirium.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-12
• Study Completion: 2013-04-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

1) Severe liver dysfunction 2) Patients given fluvoxamine 3) Alcohol dependence, amphetamine abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified