Melatonin for Delirium Prophylaxis

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium
• Intervention / Treatment: Other: Placebo; Drug: Melatonin

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Coastal Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients given once daily placebo (cellulose) orally in the evening, for 14 days.	Other: Placebo
Experimental: Melatonin; Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.	Drug: Melatonin

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay		Within 6 months
Time to delirium		Within 14 days
Discharge Functional Status (Physiotherapist or Occupational therapist assessed)	Physiotherapist or Occupational therapist assessed	Within 6 months
Discharge Disposition (Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living)	Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living	Within 6 months
Sleep (Hours slept according to nursing records)	Hours slept according to nursing records	Within 14 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Peter KY Chan, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Melatonin; Sleep; Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: H13-02843