A Phase 2 interventional study of Melatonin and Placebo in Delirium, sponsored by Ciusss de L'Est de l'Île de Montréal. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Phase 2, Interventional, and Treatment
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.
The prevalence of delirium is high in the intensive care unit (ICU), yet there is no pharmacological treatment that has been proven effective. The investigators hypothesize that melatonin, given on a daily basis at 21:00, will safely decrease the mean duration of a delirium episode in ICU patients. The current literature evaluating melatonin as a treatment for delirium is lacking, therefore more studies are needed.
It is estimated that an alteration of sleep pattern can be found in up to 75% of patients with delirium. This raises the hypothesis that prevention and treatment of sleep disorders could potentially improve delirium. Sleep and circadian rhythm disturbances are associated with low endogenous melatonin secretion and studies have shown that it also occurs in patients with delirium.
Thus, the objective is to conduct a phase II double blind, placebo-controlled randomized trial comparing melatonin 9 mg to placebo to evaluate the feasibility of a future large-scale RCT. Participants will be followed during their stay in the ICU and after their transfer on another unit up to a maximum of 14 days. Feasibility of the larger trial will mainly be based on enrollment rates.
Exclusion Criteria:
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.
Drug: Melatonin
ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.
Drug: Placebo
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.
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.
Feasibility: Enrollment rate
Average enrollment rate of participants per month.
Time frame: 8 months
Clinical: Duration of delirium
Compare the average duration of an episode of delirium defined as the number of days with ICDSC score ≥4 between the 2 groups.
Time frame: 14 days
Feasibility: Study adherence
Proportion of administered doses in the prescribed dose administration window (between 19:00 and 23:00 hours) divided by total number of eligible study days.
Time frame: 8 months
Feasibility: Consent rate
Proportion of participants recruited among eligible patients.
Time frame: 8 months
Clinical: Adverse events
Incidence of adverse events reported in the Canadian melatonin monograph (i.e. headache and nausea) observed by the investigators or reported by the treating team.
Time frame: 14 days
Feasibility: Completion of study
Proportion of participants who completed the study and reasons associated with withdrawal.
Time frame: 8 months
Feasibility: MDAS assessment time (minutes)
Time required for the administration of the Memorial Delirium Assessment Scale (MDAS). Values from 0 to 30. A higher score means a worse outcome.
Time frame: 8 months
Feasibility: Completion of ICDSC
Proportion of missing data in the completion of the Intensive Care Delirium Screening Checklist (ICDSC). Values from 0 to 8. A higher score means a worse outcome.
Time frame: 8 months
Clinical: Antipsychotics dose (mg) administered to participants
Cumulative dose of de novo antipsychotics, reported in haloperidol equivalent dose, received by participants during delirium.
Time frame: 14 days
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Ciusss de L'Est de l'Île de Montréal