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Enteral melatonin 2 mg for Delirium (MELLOW-1 Trial)

Phase 2
Waitlist Available
Led By Lisa Burry, PharmD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing whether melatonin can prevent delirium in critically ill adults in the ICU. Melatonin is a natural hormone that helps regulate sleep. By giving it regularly, researchers hope to maintain normal sleep patterns and reduce confusion. The study will also determine the best dose and check for any side effects. Another substance similar to melatonin is being tested for its potential to prevent delirium and shorten ICU stays.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility: Study adherence
Secondary outcome measures
Clinical: Adverse events
Clinical: Delirium incidence
Clinical: Delirium time to onset and duration (days)
+15 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Enteral melatonin 2 mgActive Control1 Intervention
Melatonin 2 mg from the 1mg/mL oral suspension qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration 0.4 mg/mL; final volume in the oral syringe will be 5 mL)
Group II: Enteral melatonin 0.5 mgActive Control1 Intervention
Melatonin 0.5 mg from the 1mg/mL oral suspension qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration of 0.1 mg/mL; final volume in the oral syringe will be 5 mL)
Group III: Enteral matched placeboPlacebo Group1 Intervention
Melatonin 0 mg qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration 0 mg/mL; final volume in the oral syringe will be 5 mL)

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,539 Total Patients Enrolled
2 Trials studying Delirium
3,971 Patients Enrolled for Delirium
Sunnybrook Health Sciences CentreOTHER
661 Previous Clinical Trials
1,553,982 Total Patients Enrolled
5 Trials studying Delirium
4,925 Patients Enrolled for Delirium
Hopital du Sacre-Coeur de MontrealOTHER
51 Previous Clinical Trials
12,200 Total Patients Enrolled
~9 spots leftby Sep 2025
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