Melatonin for Delirium Prophylaxis

NCT02282241 | Withdrawn Phase 4 DMC

• 1 other identifier: H13-02843
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Melatonin; Sleep; Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Confusion (Confusion Assessment Method scores)

  Within 14 days

• Mortality

  Within 14 days

• Use of restraints

  Within 14 days

• Code White (Violence)

  Within 14 days

Other Outcomes (5)

• Length of Stay

  Within 6 months

• Time to delirium

  Within 14 days

• Discharge Functional Status (Physiotherapist or Occupational therapist assessed)

  Within 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients given once daily placebo (cellulose) orally in the evening, for 14 days.

Other: Placebo

Melatonin

EXPERIMENTAL

Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.

Drug: Melatonin

Interventions

Melatonin DRUG

Melatonin

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or greater
• Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Peter KY Chan, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Peter Chan

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 4, 2014
• Study Start: February 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-09

Locations

CA (1)