Melatonin for Delirium Prophylaxis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Delirium (Confusion Assessment Method) [Within 14 days]
Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician.
Secondary Outcome Measures
- Confusion (Confusion Assessment Method scores) [Within 14 days]
Confusion Assessment Method scores.
- Mortality [Within 14 days]
- Use of restraints [Within 14 days]
- Code White (Violence) [Within 14 days]
Other Outcome Measures
- Length of Stay [Within 6 months]
- Time to delirium [Within 14 days]
- Discharge Functional Status (Physiotherapist or Occupational therapist assessed) [Within 6 months]
Physiotherapist or Occupational therapist assessed
- Discharge Disposition (Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living) [Within 6 months]
Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living
- Sleep (Hours slept according to nursing records) [Within 14 days]
Hours slept according to nursing records
Eligibility Criteria
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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vancouver Coastal Health | Vancouver | British Columbia | Canada | V5Z 1M9 |
Sponsors and Collaborators
- University of British Columbia
Investigators
- Principal Investigator: Peter KY Chan, MD, University of British Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H13-02843