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
Among 20 studies testing melatonin in Delirium — 3 open to participants now, 4 under way, none of them phase 3. Melatonin · Delirium.
Among the 20 studies testing melatonin in Delirium, this one is the 16th largest by planned enrollment, is one of 2 that started in 2023, is one of 3 in phase 2, and was the 19th registered.
933 studies on the registry are indexed under Delirium; 189 are open to participants now.
Browse Delirium studies →3 of the 20 studies testing melatonin in Delirium are open now, in 3 countries. Recruiting first, the newest first:
Tanta University · Sites in Egypt
Ages 21+
University Hospital, Basel, Switzerland · Sites in Switzerland
Ages 55+
By country, each count listing its studies:
Melatonin: first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 127 Delirium studies recruiting now, 99 (78%) set no upper age limit and 8 (6%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 5 · Phase 4 4
First in 2007; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 112 across 550 interventional studies indexed under Delirium.
Median enrollment 97 across the 20 interventional studies. Of the 11 that completed or were terminated, 2 (18%) have results posted.
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None of the 20 has an industry lead sponsor. The 10 most frequent:
Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 90 studies on the registry; 32 are open to participants now.
Ciusss de L'Est de l'Île de Montréal has 2 studies filed under Delirium — fewer than ten, so there is no comparison to draw.
1 of the studies testing melatonin in Delirium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05713877Ciusss de L'Est de l'Île de MontréalMelatonin for Treatment of Delirium in Critically Ill Adult Patients | 2026-12-30 |
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Among the 20 studies testing melatonin in Delirium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Feb 2023 (actual). Primary completion is estimated for Dec 2026, 46 months after the start.
Of 19 phase 2 interventional studies under Delirium, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 46. This study's planned 46 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Melatonin
Ciusss de L'Est de l'Île de Montréal