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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

Tracking Information
First Submitted Date  ICMJE October 30, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 3, 2014)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Melatonin for Delirium Prophylaxis
Official Title  ICMJE A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Delirium
Intervention  ICMJE
  • Drug: Melatonin
  • Other: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients given once daily placebo (cellulose) orally in the evening, for 14 days.
    Intervention: Other: Placebo
  • Experimental: Melatonin
    Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.
    Intervention: Drug: Melatonin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2017
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282241
Other Study ID Numbers  ICMJE H13-02843
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter KY Chan, MD University of British Columbia
PRS Account University of British Columbia
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP