Melatonin for Delirium Prophylaxis

Phase 4

Withdrawn

• Conditions: Delirium
• Interventions: Other: Placebo; Drug: Melatonin

• Registration Number: NCT02282241
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Study Start: 2016-02
• Status Verified: 2021-09
• Primary Completion: 2021-09
• Study Completion: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients given once daily placebo (cellulose) orally in the evening, for 14 days.
Melatonin	Melatonin	Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mortality	Within 14 days
Use of restraints	Within 14 days
Confusion (Confusion Assessment Method scores)	Within 14 days	Confusion Assessment Method scores.
Code White (Violence)	Within 14 days

Trial Locations

Locations (1)

Vancouver Coastal Health; 🇨🇦 Vancouver, British Columbia, Canada