Melatonin for Delirium
(DELIRE-ICU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test if melatonin can help reduce delirium in critically ill ICU patients by improving their sleep. Delirium is common in these patients, and there are no effective drug treatments currently available. By regulating sleep, melatonin might shorten the duration of delirium episodes. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot have used melatonin within 24 hours before joining the trial.
Is melatonin safe for humans?
How does melatonin differ from other drugs for delirium?
Melatonin is unique in its use for delirium because it is a natural hormone that helps regulate sleep-wake cycles, and it is well-tolerated with few side effects. Unlike other drugs, melatonin focuses on correcting circadian rhythm disruptions, which are thought to contribute to delirium, rather than directly targeting symptoms or behaviors.12567
What data supports the effectiveness of the drug melatonin for delirium?
Who Is on the Research Team?
François Marquis, M.D., M.A.
Principal Investigator
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est-de-l'Île-de-Montréal
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive melatonin 9 mg or placebo daily at 21:00 to treat delirium in the ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment during their stay in the ICU and after transfer to another unit
What Are the Treatments Tested in This Trial?
Interventions
- Melatonin
- Placebo
Melatonin is already approved in European Union, United States for the following indications:
- Insomnia in adults aged 55 and over
- Sleep disorders in children with autism spectrum disorder
- Insomnia in children and adolescents aged 2-18 with autism spectrum disorder
- Sleep disorders in children with autism spectrum disorder
- Insomnia in adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor
Maisonneuve-Rosemont Hospital
Collaborator