Clinical trial NCT02282241: Melatonin for Delirium Prophylaxis
Official title: A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Delirium
Keywords: Melatonin
Sleep
Delirium
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Delirium (Confusion Assessment Method)
timeFrame: Within 14 days
Secondary outcomes:
measure: Confusion (Confusion Assessment Method scores)
timeFrame: Within 14 days
measure: Mortality
timeFrame: Within 14 days
measure: Use of restraints
timeFrame: Within 14 days
measure: Code White (Violence)
timeFrame: Within 14 days
Other outcomes:
measure: Length of Stay
timeFrame: Within 6 months
measure: Time to delirium
timeFrame: Within 14 days
measure: Discharge Functional Status (Physiotherapist or Occupational therapist assessed)
timeFrame: Within 6 months
measure: Discharge Disposition (Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living)
timeFrame: Within 6 months
measure: Sleep (Hours slept according to nursing records)
timeFrame: Within 14 days
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Peter KY Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: