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Melatonin for Delirium Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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
Delirium Drug: Melatonin Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Confusion (Confusion Assessment Method scores) [ Time Frame: Within 14 days ]
    Confusion Assessment Method scores.

  2. Mortality [ Time Frame: Within 14 days ]
  3. Use of restraints [ Time Frame: Within 14 days ]
  4. Code White (Violence) [ Time Frame: Within 14 days ]

Other Outcome Measures:
  1. Length of Stay [ Time Frame: Within 6 months ]
  2. Time to delirium [ Time Frame: Within 14 days ]
  3. Discharge Functional Status (Physiotherapist or Occupational therapist assessed) [ Time Frame: Within 6 months ]
    Physiotherapist or Occupational therapist assessed

  4. 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

  5. Sleep (Hours slept according to nursing records) [ Time Frame: Within 14 days ]
    Hours slept according to nursing records



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Peter KY Chan, MD 604-875-4056 peter.chan@ubc.ca

Locations
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Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Peter KY Chan, MD    604-875-4056    pechan@mail.ubc.ca   
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         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Peter KY Chan, MD University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02282241    
Other Study ID Numbers: H13-02843
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Keywords provided by University of British Columbia:
Melatonin
Sleep
Delirium
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants