NCT05713877 Melatonin for Treatment of Delirium in Critically Ill Adult Patients
| NCT ID | NCT05713877 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ciusss de L'Est de l'Île de Montréal |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-02-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.
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.
Contact & Investigator
Johannie Beaucage-Charron, Pharm.D., M.Sc.
✉ johannie.beaucage-charron.cemtl@ssss.gouv.qc.ca📞 514 252 3400
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
Frequently Asked Questions
Who can join the NCT05713877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05713877 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05713877 currently recruiting?
Yes, NCT05713877 is actively recruiting participants. Contact the research team at johannie.beaucage-charron.cemtl@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05713877 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05713877 clinical trial?
NCT05713877 is sponsored by Ciusss de L'Est de l'Île de Montréal. The principal investigator is François Marquis, M.D., M.A. at Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est-de-l'Île-de-Montréal. The trial plans to enroll 30 participants.