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RECRUITING
NCT05713877
PHASE2

Melatonin for Treatment of Delirium in Critically Ill Adult Patients

Sponsor: Ciusss de L'Est de l'Île de Montréal

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-02-01

Completion Date

2026-12-30

Last Updated

2026-03-23

Healthy Volunteers

No

Conditions

Interventions

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.

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.

Locations (1)

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada