Melatonin for Delirium
(MIND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test if melatonin, a natural sleep hormone, can prevent delirium in elderly surgical patients. Delirium is a common and serious issue for these patients, and melatonin might help by improving their sleep. Melatonin is a hormone produced by the pineal gland and has been used successfully for various medical conditions, especially sleep-related diseases.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are already taking melatonin, you cannot participate in the trial.
Is melatonin safe for use in humans?
How does melatonin differ from other drugs for delirium?
Melatonin is unique because it is a natural hormone that helps regulate sleep, and it is being explored for its potential to prevent delirium, especially in older adults and critically ill patients, by improving sleep and stabilizing the day-night cycle. Unlike other treatments, there is currently no standard drug that effectively prevents delirium, making melatonin a novel option in this area.12346
What data supports the effectiveness of the drug Liquid Melatonin for treating delirium?
Are You a Good Fit for This Trial?
This trial is for people over 65 who are having major non-cardiac surgery and will stay in the hospital for at least two days. They must be able to agree to the study themselves. It's not for those with active delirium or dementia, current melatonin use, trouble taking pills by mouth, planned breathing support after surgery, past study participation, melatonin allergy, severe liver problems, language barriers or unwillingness to participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 mg of liquid melatonin or placebo by oral route for 8 days, starting 1-2 hours prior to surgery and continuing with bedtime doses until discharge or for the first 7 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cognitive status and incidence of delirium.
What Are the Treatments Tested in This Trial?
Interventions
- Liquid Melatonin
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
St. Joseph's Healthcare Hamilton
Collaborator