Using melatonin to treat delirium in critically ill adults

DELIRE-ICU: A Randomised Controlled Feasibility Trial of Melatonin vs Placebo in the Treatment of Delirium in the Intensive Care Unit

This study is testing if giving melatonin to critically ill adults can help reduce the time they experience delirium while in the ICU.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ciusss de L'Est de l'Île de Montréal (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05713877 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are admitted to the ICU and expected to stay for more than 48 hours with a delirium score indicating significant symptoms.

Not a fit: Patients with severe brain injuries, major neurocognitive disorders, or those diagnosed with certain psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new pharmacological treatment option for delirium in critically ill patients.

How similar studies have performed: While the current literature on melatonin for delirium is limited, the approach is novel and has not been extensively tested in this specific context.

Eligibility criteria

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 this trial is running

Montreal, Quebec

• 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.

Conditions Delirium; Melatonin; Intensive care; Feasibility; Treatment; Critically ill; ICU