Melatonin for Delirium Prophylaxis

Study Overview
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Brief Summary
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Delirium is a common complication of illness especially among the elderly with serious sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric emergency has key features including acute onset, fluctuating level of consciousness, poor attention and cognitive deficits with a presentation which may include hallucinations and delusions. A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is a widely available natural health product with evidence in normalizing circadian rhythms and sleep. There is also preliminary evidence that melatonin can be used to prevent the development of delirium in hospitalized patients. We hypothesize that daily administration of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison subjects.

Official Title
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A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium

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: 65 years of age or greater Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards. Exclusion Criteria: those who are suspected to be delirious at the time of their initial presentation; those who are already taking melatonin prior to admission; those who are not expected to live more than 48 hours; those suffering severe dementia (as indicated by a score of 6-7 on the Global Deterioration Scale adapted by Dr. Doug Drummond from Reisberg et al. (Reisberg 1982); those who are unable to reliably take oral medications; those presenting with an intracranial bleed, seizure or acute stroke; those with a known allergy or adverse reaction to the study compounds; those who cannot be evaluated initially because of depressed level of consciousness or inability to communicate; those anticipated to require surgery early in their hospitalization.

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients given once daily placebo (cellulose) orally in the evening, for 14 days. | Other: Placebo<br> <br> |
| Experimental: Melatonin<br>Patients given once daily melatonin 1.5mg orally in the evening, for 14 days. | Drug: Melatonin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium (Confusion Assessment Method) | Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician. | Within 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confusion (Confusion Assessment Method scores) | Confusion Assessment Method scores. | Within 14 days | 
| Mortality |  | Within 14 days | 
| Use of restraints |  | Within 14 days | 
| Code White (Violence) |  | Within 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Sleep, Delirium