Prevention of Delirium in Inpatients Utilizing Melatonin

Study Overview
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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.

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.

Official Title
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Prevention of Delirium in Inpatients Utilizing Melatonin

Conditions
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Delirium

Intervention / Treatment
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* Drug: Melatonin
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>5 mg Melatonin nightly, beginning within 24 hours of admission | Drug: Melatonin<br>* 5 mg Melatonin nightly, beginning within 24 hours of admission<br>|
| Placebo Comparator: Cellulose Microcrystylline<br>Blue capsule matching the melatonin arm | Other: Placebo<br>* Blue capsule matching the melatonin arm<br>* Other names: Cellulose Microcrystylline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization. | length of hospitalization, not to exceed 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Length of stay is defined as the total time hospitalized for the acute illness (in days). | from day of admission to completion of acute care, not to exceed 30 days | 
| Days Utilizing Restraints | Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization. | length of hospitalization, not to exceed 14 days | 
| Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization. | Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization. | length of hospitalization, not to exceed 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention; delirium; in-patients; melatonin,