Melatonin for Prevention of Delirium in Critically Ill Patients (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

All Individual Drugs Already Approved

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.

Eligible Conditions

Delirium

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility: Study adherence

Secondary study objectives

Clinical: Adverse events

Clinical: Delirium incidence

Clinical: Delirium time to onset and duration (days)

+15 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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)

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