Status:

WITHDRAWN

Melatonin for Delirium Prophylaxis

Lead Sponsor:

University of British Columbia

Conditions:

Delirium

Eligibility:

All Genders

65+ years

Phase:

PHASE4

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 fea...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

February 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2021

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02282241

Start Date

February 1 2016

End Date

September 1 2021

Last Update

October 7 2021

Active Locations (1)

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Vancouver Coastal Health

Vancouver, British Columbia, Canada, V5Z 1M9