Melatonin for Delirium Prophylaxis
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|ClinicalTrials.gov Identifier: NCT02282241|
Recruitment Status : Unknown
Verified July 2015 by University of British Columbia.
Recruitment status was: Not yet recruiting
First Posted : November 4, 2014
Last Update Posted : July 31, 2015
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|
|Delirium||Drug: Melatonin Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||February 2017|
Placebo Comparator: Placebo
Patients given once daily placebo (cellulose) orally in the evening, for 14 days.
Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.
- Delirium (Confusion Assessment Method) [ Time Frame: 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.
- Confusion (Confusion Assessment Method scores) [ Time Frame: Within 14 days ]Confusion Assessment Method scores.
- Mortality [ Time Frame: Within 14 days ]
- Use of restraints [ Time Frame: Within 14 days ]
- Code White (Violence) [ Time Frame: Within 14 days ]
- Length of Stay [ Time Frame: Within 6 months ]
- Time to delirium [ Time Frame: Within 14 days ]
- Discharge Functional Status (Physiotherapist or Occupational therapist assessed) [ Time Frame: Within 6 months ]Physiotherapist or Occupational therapist assessed
- Discharge Disposition (Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living) [ Time Frame: Within 6 months ]Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living
- Sleep (Hours slept according to nursing records) [ Time Frame: Within 14 days ]Hours slept according to nursing records
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282241
|Contact: Peter KY Chan, MDemail@example.com|
|Canada, British Columbia|
|Vancouver Coastal Health|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Peter KY Chan, MD 604-875-4056 firstname.lastname@example.org|
|Principal Investigator: Peter Y Chan, MD|
|Sub-Investigator: Alexander McGirr, MD MSc|
|Sub-Investigator: Jennifer Li, MD PhD|
|Sub-Investigator: Mario McKenna, PhD|
|Sub-Investigator: Jesse Sidhu, MD|
|Principal Investigator:||Peter KY Chan, MD||University of British Columbia|