Prevention of Delirium in Inpatients Utilizing Melatonin

• Status: Terminated
• Trial end date: 2017-11-03
• Target enrollment: 0
• Participant gender: All

Summary

A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Inpatient admission to a general internal medicine service

Exclusion Criteria:

• expected lifespan or length of stay ≤ 48 hours

• Non-English speaking

• Already taking melatonin or ramelteon at the time of randomization

• Presence of delirium at the time of randomization

• Unable to take oral medications

• Subject or proxy unable to provide informed consent within 18 hours of invitation or 24 hours of admission

• ALT or AST (Liver function tests) > 3 times the upper limit of normal

• Taking warfarin, nifedipine or fluvoxamine

• Allergy to melatonin

• Unable to recall 3 words after distraction by naming the days of the week backwards beginning with Sunday