Melatonin for Delirium Prophylaxis

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02282241
• Other study ID #: H13-02843
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: September 2021

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Melatonin

Other:
• Placebo

Locations

Country	Name	City	State
Canada	Vancouver Coastal Health	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Stay		Within 6 months
Other	Time to delirium		Within 14 days
Other	Discharge Functional Status (Physiotherapist or Occupational therapist assessed)	Physiotherapist or Occupational therapist assessed	Within 6 months
Other	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
Other	Sleep (Hours slept according to nursing records)	Hours slept according to nursing records	Within 14 days
Primary	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	Confusion (Confusion Assessment Method scores)	Confusion Assessment Method scores.	Within 14 days
Secondary	Mortality		Within 14 days
Secondary	Use of restraints		Within 14 days
Secondary	Code White (Violence)		Within 14 days