Melatonin for Delirium Prophylaxis

NCT ID: NCT02282241

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Melatonin

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

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

Interventions

Melatonin

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Peter Y Chan

Dr. Peter Chan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter KY Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H13-02843

Identifier Type: -

Identifier Source: org_study_id