Recruiting

Phase 2

MelatoninMelatonin for Treatment of Delirium in Critically Ill Adult Patients

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT05713877

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Melatonin

Placebo

Study Details

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.

Conditions

Delirium

Study ID

NCT05713877

Start date

Feb 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enteral melatonin 9 mg

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.

placebo comparator: Enteral placebo

ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.

Interventions

Melatonin

Study drug will be given at 21:00 daily, starting on the day of enrolment until delirium resolution, hospital discharge, death, or up to 14 days. The study medication will be given by mouth (PO or per os) or, if needed, via the feeding tube.

Placebo

Primary outcome measure

Feasibility: Enrollment rate [ Time Frame: 8 months ]
Clinical: Duration of delirium [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Johannie Beaucage-Charron, Pharm.D., M.Sc.

514 252 3400 johannie.beaucage-charron.cemtl@ssss.gouv.qc.ca

Locations

Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Mar 23, 2026

Last verified

Feb, 2026

Keywords

Melatonin
Intensive care
Feasibility
Treatment
Critically ill
ICU

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2026-03-23.