Prevention of Delirium in Inpatients Utilizing Melatonin

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-11-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

5 mg Melatonin nightly, beginning within 24 hours of admission

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

5 mg Melatonin nightly, beginning within 24 hours of admission

Cellulose Microcrystylline

Blue capsule matching the melatonin arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Blue capsule matching the melatonin arm

Interventions

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Melatonin

5 mg Melatonin nightly, beginning within 24 hours of admission

Intervention Type DRUG

Placebo

Blue capsule matching the melatonin arm

Intervention Type OTHER

Other Intervention Names

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Cellulose Microcrystylline

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No