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Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

This study has been completed.
University of Western Ontario, Canada
Information provided by:
Lawson Health Research Institute Identifier:
First received: March 31, 2009
Last updated: July 6, 2009
Last verified: July 2009
122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.

Condition Intervention Phase
Dietary Supplement: melatonin
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • delirious using confusion assessment method (CAM) [ Time Frame: days ]

Secondary Outcome Measures:
  • MDAS (memorial delirium assessment scale) [ Time Frame: days ]

Enrollment: 122
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: melatonin
.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380)
Dietary Supplement: melatonin
one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada
Placebo Comparator: placebo
half a white placebo tablet
Dietary Supplement: placebo
half a white placebo tablet


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

Inclusion Criteria:

  • Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.

Exclusion Criteria:

  • Life expectancy less than 24 hours,
  • Unable to communicate in English,
  • Unable to take oral medications,
  • Intracranial bleed or known seizure disorder,
  • Markedly sub or supra-therapeutic INR while on warfarin, OR
  • A known allergy to study tablet ingredients.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00873379

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, n6a5a5
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Principal Investigator: Chris Brymer, MD University of Western Ontario, Canada
  More Information

Responsible Party: Chris brymer, Lawson Health Research Institute Identifier: NCT00873379     History of Changes
Other Study ID Numbers: R-07-314
Study First Received: March 31, 2009
Last Updated: July 6, 2009

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on April 26, 2017