drugset / Trial / NCT02282241

Melatonin for Delirium Prophylaxis

NCT02282241

Phase 4 Withdrawn University of British Columbia
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2016-02
Primary completion
2021-09
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 1.5 mg Oral

Indications