Melatonin for Delirium Prophylaxis

University of British Columbia

Status and phase

Withdrawn

Phase 4

Conditions

Delirium

Treatments

Drug: Melatonin

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02282241

H13-02843

Details and patient eligibility

About

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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.