Hormone Therapy

Melatonin for Delirium

Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Must not have
Be younger than 65 years old
Screening 3 weeks
Treatment Varies
Follow Up6 months
Awards & highlights

Study Summary

This trial is testing whether melatonin can decrease the incidence of postoperative delirium in elderly patients.

Eligible Conditions
  • Noncardiac Surgery
  • Delirium


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more
Secondary outcome measures
Adverse effects
Cognitive Status
Incidence of Delirium
+6 more

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 site

Who is running the clinical trial?

McMaster UniversityLead Sponsor
855 Previous Clinical Trials
2,505,802 Total Patients Enrolled
6 Trials studying Delirium
3,965 Patients Enrolled for Delirium
St. Joseph's Healthcare HamiltonOTHER
190 Previous Clinical Trials
25,276 Total Patients Enrolled

Media Library

Liquid Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03785158 — N/A
Delirium Research Study Groups: Melatonin, Placebo Group
Delirium Clinical Trial 2023: Liquid Melatonin Highlights & Side Effects. Trial Name: NCT03785158 — N/A
Liquid Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03785158 — N/A

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
~13 spots leftby Jan 2024