Prevention of Delirium in Inpatients Utilizing Melatonin

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Delirium

In brief

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.

Key facts

Study ID

NCT02654314

Run by

Yale University

People needed

277

Starts

2016-07-01

Expected to finish

2017-11-03

Last updated by the study team

2022-03-21

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inpatient admission to a general internal medicine service

You may not qualify if…

• 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

Where it is running

• Yale New Haven Hospital, Saint Raphael Campus — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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