Melatonin for Treatment of Delirium in Critically Ill Adult Patients (DELIRE-ICU)

March 19, 2026 updated by: Ciusss de L'Est de l'Île de Montréal

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont
        • Contact:
          • Johannie Beaucage-Charron, Pharm.D., M.Sc.
        • Sub-Investigator:
          • Katerine Chalifoux, Pharm.D.
        • Sub-Investigator:
          • Marianne Leblanc, Pharm.D.
        • Sub-Investigator:
          • Mounia Louerguioui, Pharm.D.
        • Sub-Investigator:
          • Patricia Poirier, Pharm.D.
        • Sub-Investigator:
          • Aryane Roy, B.Pharm.
        • Sub-Investigator:
          • Winnie Tran, Pharm.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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 Comparator: Enteral placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Enrollment rate
Time Frame: 8 months
Average enrollment rate of participants per month.
8 months
Clinical: Duration of delirium
Time Frame: 14 days
Compare the average duration of an episode of delirium defined as the number of days with ICDSC score ≥4 between the 2 groups.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Study adherence
Time Frame: 8 months
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.
8 months
Feasibility: Consent rate
Time Frame: 8 months
Proportion of participants recruited among eligible patients.
8 months
Clinical: Adverse events
Time Frame: 14 days
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.
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Completion of study
Time Frame: 8 months
Proportion of participants who completed the study and reasons associated with withdrawal.
8 months
Clinical: Antipsychotics dose (mg) administered to participants
Time Frame: 14 days
Cumulative dose of de novo antipsychotics, reported in haloperidol equivalent dose, received by participants during delirium.
14 days
Feasibility: MDAS assessment time (minutes)
Time Frame: 8 months

Time required for the administration of the Memorial Delirium Assessment Scale (MDAS).

Values from 0 to 30. A higher score means a worse outcome.
8 months
Feasibility: Completion of ICDSC
Time Frame: 8 months

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.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

Maisonneuve-Rosemont Hospital

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-3247

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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