Your session is about to expire
← Back to Search
Other
Melatonin for Delirium (DELIRE-ICU Trial)
Phase 2
Recruiting
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
Timeline
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
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 moreSide effects data
From 2014 Phase 2 trial • 40 Patients • NCT0111437342%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Find a Location
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,530 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor expects my illness to significantly impact my life expectancy in the short term.I was diagnosed with delirium before being admitted to the ICU.I do not have active seizures, coma, aphasia, or severe intellectual disability.I cannot take medicine by mouth due to a medical condition.I have been diagnosed with schizophrenia, bipolar disorder, psychotic depression, uremic encephalopathy, or am experiencing alcohol withdrawal.I have not taken melatonin in the last 24 hours.I cannot understand or speak English or French.I am completely blind.Your ICDSC score is 4 or higher for up to 48 hours before being chosen by chance to be in the study.I have a severe brain injury or advanced brain condition.I am 18 or older and have been admitted to the ICU.I expect to stay in the ICU for more than 48 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Enteral melatonin 9 mg
- Group 2: Enteral placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger