Enteral melatonin 9 mg for Delirium

Phase-Based Progress Estimates
Hopital Maisonneuve-Rosemont, Montréal, CanadaDeliriumMelatonin - Drug
All Sexes
What conditions do you have?

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 8 months

14 days
Clinical: Adverse events
Clinical: Antipsychotics dose (mg) administered to participants
Clinical: Duration of delirium
8 months
Feasibility: Completion of ICDSC
Feasibility: Completion of study
Feasibility: Consent rate
Feasibility: Enrollment rate
Feasibility: MDAS assessment time (minutes)
Feasibility: Study adherence

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

39%Early Morning Wakening
36%Daytime drowsiness
11%Blurred vision
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01114373) in the Melatonin ARM group. Side effects include: Fatigue with 42%, Early Morning Wakening with 39%, Daytime drowsiness with 36%, Dizziness with 11%, Blurred vision with 11%.

Trial Design

2 Treatment Groups

Enteral melatonin 9 mg
1 of 2
Enteral placebo
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Enteral melatonin 9 mg · Has Placebo Group · Phase 2

Enteral melatonin 9 mg
Experimental Group · 1 Intervention: Melatonin · Intervention Types: Drug
Enteral placebo
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
58 Previous Clinical Trials
3,971 Total Patients Enrolled
1 Trials studying Delirium
23 Patients Enrolled for Delirium
Maisonneuve-Rosemont HospitalOTHER
97 Previous Clinical Trials
36,424 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

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.