Prevention of Delirium in Inpatients Utilizing Melatonin (PODIUM)

Yale University

Status and phase

Terminated

Phase 3

Conditions

Delirium

Treatments

Other: Placebo

Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT02654314

1601017038

Details and patient eligibility

About

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.

Full description

This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.

Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged.

Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.

Enrollment

277 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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