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Melatonin for Delirium (DELIRE-ICU Trial)

Phase 2
Led By François Marquis, M.D., M.A.
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

DELIRE-ICU Trial Summary

This trial will study the use of melatonin to treat delirium in critically ill adults. Results will help determine if a larger study is needed.

Who is the study for?
Adults over 18 in the ICU with a recent delirium score of at least 4, expected to stay in the ICU for more than 48 hours. Not eligible if they have severe brain injuries, major cognitive disorders, certain psychiatric diagnoses, seizures, coma, are pregnant or breastfeeding, took melatonin recently or can't take oral meds.Check my eligibility
What is being tested?
The trial is testing whether giving melatonin to critically ill adults helps treat delirium compared to a placebo. It's set up as a small-scale study first to see if it's possible to do a larger one later.See study design
What are the potential side effects?
While not specified here, common side effects of melatonin may include drowsiness, headache and mild dizziness. Since this is about feasibility, close monitoring will likely identify any other potential side effects.

DELIRE-ICU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Clinical: Duration of delirium
Feasibility: Enrollment rate
Secondary outcome measures
Clinical: Adverse events
Feasibility: Consent rate
Feasibility: Study adherence
Other outcome measures
Clinical: Antipsychotics dose (mg) administered to participants
Feasibility: Completion of ICDSC
Feasibility: Completion of study
+1 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
Early Morning Wakening
Daytime drowsiness
Blurred vision
Study treatment Arm

DELIRE-ICU Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Enteral melatonin 9 mgExperimental Treatment1 Intervention
Melatonin 9 mg from a 1 mg/mL oral suspension of melatonin in ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.
Group II: Enteral placeboPlacebo Group1 Intervention
ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
71 Previous Clinical Trials
5,531 Total Patients Enrolled
1 Trials studying Delirium
23 Patients Enrolled for Delirium
Maisonneuve-Rosemont HospitalOTHER
99 Previous Clinical Trials
36,293 Total Patients Enrolled
2 Trials studying Delirium
1,314 Patients Enrolled for Delirium
François Marquis, M.D., M.A.Principal InvestigatorCentre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est-de-l'Île-de-Montréal

Media Library

Melatonin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05713877 — Phase 2
Delirium Research Study Groups: Enteral melatonin 9 mg, Enteral placebo
Delirium Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT05713877 — Phase 2
Melatonin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05713877 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous could the ingestion of Enteral melatonin 9 mg be to individuals?

"Our experts at Power rated the safety of Enteral melatonin 9 mg as a 2 due to there being some evidence that it is secure, but no proof of its efficacy."

Answered by AI

Are there any available openings for participants in this clinical trial?

"Data from clinicaltrials.gov implies that this particular medical trial is not currently garnering participants, despite being posted on the 1st of February 2021 and edited 6 days later. Although recruitment has ceased in this study, 145 other trials are actively accepting volunteers at present."

Answered by AI
~6 spots leftby Sep 2024