Using melatonin to treat delirium in critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the feasibility of conducting a randomized controlled trial using melatonin to treat delirium in critically ill adult patients. The investigators hypothesize that administering melatonin daily at 21:00 will reduce the duration of delirium episodes in ICU patients. The study will be a phase II double-blind, placebo-controlled trial, with participants monitored during their ICU stay and up to 14 days after transfer to another unit. The primary focus is on achieving adequate enrollment rates to support a larger future trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18 years or older admitted to the intensive care unit;
* Anticipated ICU stay \> 48 hours;
* ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.

Exclusion Criteria:

* Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®;
* Use of melatonin within 24 hours prior to randomization;
* Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy;
* Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal;
* Presence of active seizures, coma, aphasia or severe intellectual disability;
* Limited short-term vital prognosis;
* Diagnosis of delirium prior to ICU admission;
* Pregnancy or breastfeeding;
* Absolute contraindication to receive enteral medication;
* Inability to understand or speak English or French;
* Total blindness.

Where it's running

• Hopital Maisonneuve-Rosemont
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: François Marquis, M.D., M.A. — Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est-de-l'Île-de-Montréal
• Study coordinator: Johannie Beaucage-Charron, Pharm.D., M.Sc.
• Email: johannie.beaucage-charron.cemtl@ssss.gouv.qc.ca
• Phone: 514 252 3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.