Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Dietary supplement: melatonin; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
delirious using confusion assessment method (CAM)	days

Secondary Outcome Measures

Outcome Measure	Time Frame
MDAS (memorial delirium assessment scale)	days

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: University of Western Ontario, Canada
• Investigators: Principal Investigator: Chris Brymer, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Estimate): July 7, 2009
• Last Update Submitted That Met QC Criteria: July 6, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: R-07-314; 13426

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No