Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can melatonin help ICU patients snap out of delirium?

NCT ID NCT05713877

Symptom relief Sponsor: Ciusss de L'Est de l'Île de Montréal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether melatonin, a natural sleep hormone, can help treat delirium in intensive care unit (ICU) patients. Delirium is a state of confusion and disorientation common in critically ill people. The trial will give 30 patients either melatonin or a placebo every evening for up to 14 days. The main goal is to see if a larger study is possible, and to check if melatonin shortens the time patients remain delirious.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If it works, this could point toward a simple, safe treatment to reduce delirium duration in critically ill patients.
What could go wrong
This is a very small feasibility trial with only 30 participants, so results may not be conclusive. Delirium has many causes, and melatonin may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Delirium are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Critical Illness delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Delirium

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hopital Maisonneuve-Rosemont

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.