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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

MELLOW-1 Trial Summary

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for prevention of delirium in critically ill adult patients. The investigators hypothesize that melatonin, administered on a scheduled nightly basis during ICU admission, will be efficacious and safe for the prevention of delirium in critically ill adults.

MELLOW-1 Trial 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

MELLOW-1 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
656 Previous Clinical Trials
1,550,553 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Melatonin for Prevention of Delirium in Critically Ill Patients
2017. "Melatonin for Prevention of Delirium in Critically Ill Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02615340.
All > Melatonin
~9 spots leftby Apr 2025
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