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OpenTrials
Completed

NCT Number: NCT00873379

Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre

London, Ontario, n6a5a5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada

Placebo

Dietary Supplement

half a white placebo tablet

Primary outcomes

  1. delirious using confusion assessment method (CAM)

    Time frame: days

Secondary outcomes

  1. MDAS (memorial delirium assessment scale)

    Time frame: days

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • University of Western Ontario, Canada

Registry information

Official study title

Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 1, 2009
Registry last updated
Jul 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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