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Hormone Therapy
Melatonin for Delirium (MIND Trial)
N/A
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >65 years
Having a major non-cardiac surgery with an expected hospital stay of 2 days or more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MIND Trial Summary
This trial is testing whether melatonin can decrease the incidence of postoperative delirium in elderly patients.
Who is the study for?
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.Check my eligibility
What is being tested?
The MIND After Surgery trial is testing if liquid melatonin can prevent delirium in elderly patients after surgery compared to a placebo (a substance with no active drug). Participants are randomly chosen to receive either melatonin or placebo to see if there's a difference in how often they experience confusion and memory problems post-surgery.See study design
What are the potential side effects?
Melatonin may cause drowsiness, headache, dizziness or nausea. However it's generally considered safe with few side effects when used short-term. The placebo should have no side effects since it doesn't contain any active medication.
MIND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 65 years.
Select...
I am scheduled for a major surgery that is not heart-related and will be in the hospital for at least 2 days.
MIND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Follow up to 3 months
Medication compliance
Proportion of patients recruited from screening
+1 moreSecondary outcome measures
Adverse effects
Cognitive Status
Incidence of Delirium
+6 moreMIND Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: MelatoninActive Control1 Intervention
3 mg of liquid melatonin by oral route for 8 days. The 1st dose will be given 1-2 hours prior to the surgery, followed by bed time doses (between 7-9 pm) given on postoperative day (POD) 1 until discharge or for the first 7 days.
Group II: Placebo GroupPlacebo Group1 Intervention
Similar looking/tasting 3 mg (5 ml) placebo syrup administered preoperatively by oral route and for the next 7 days or until discharge. The 1st dose will be given 1-2 hours prior to the surgery, followed by bed time doses (between 7-9 pm) given on postoperative day (POD) 1 until discharge or for the first 7 days.
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,802 Total Patients Enrolled
6 Trials studying Delirium
3,965 Patients Enrolled for Delirium
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,456 Total Patients Enrolled
1 Trials studying Delirium
20 Patients Enrolled for Delirium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 65 years.I cannot take medications by mouth.I am not willing to participate in the trial.My liver enzyme (ALT) level is above 500 IU/L.You cannot speak the language used in the study.I am scheduled for a major surgery that is not heart-related and will be in the hospital for at least 2 days.I am currently taking melatonin.You currently have a serious problem with confusion or memory loss.You are allergic to melatonin.You have participated in a previous study.I will need help breathing after my surgery.I have had a liver transplant or my liver disease is moderate to severe.
Research Study Groups:
This trial has the following groups:- Group 1: Melatonin
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main goals of this experiment?
"The primary endpoint of this medical trial, which will span approximately 3 months, is to monitor the rate of recruitment. Secondary objectives include assessing the severity of delirium using the Confusion Assessment Method (CAM) severity form, measuring ICU care requirements during hospitalization and recording presence or absence of delirium through utilization of either CAM-short form or CAM-ICU tool depending on whether a patient is mechanically ventilated."
Answered by AI
What is the current enrollment for this clinical trial?
"Affirmative. The clinicaltrial.gov website states that this trial is currently enrolling patients, with the initial listing posted on September 14th 2021 and last updated October 1st 2021. In total, 120 participants are being sought from two different study sites."
Answered by AI
Are there any new opportunities to partake in this research?
"According to the clinicaltrials.gov database, this clinical trial is presently engaging in participant recruitment efforts; the initial post was made on September 14th of 2021 and a subsequent update was issued one month later."
Answered by AI
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