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Can melatonin help ICU patients snap out of delirium?

NCT ID NCT03438526

Symptom relief Sponsor: University Hospital, Basel, Switzerland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving melatonin at bedtime can help older ICU patients (55+) recover faster from hypoactive delirium, a state of confusion and low activity. Researchers will compare melatonin to a placebo in 190 patients, measuring how long delirium lasts and overall recovery. The goal is to restore normal sleep-wake cycles and improve outcomes.

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 provide a simple, safe way to reduce delirium duration and improve recovery in older ICU patients.
What could go wrong
This is a small, early-phase trial with 190 participants. Melatonin may not outperform placebo, and results may not apply to all ICU patients.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 190 people

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

Started

Jan 2022

Expected to finish

Dec 2027

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

55 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: Participants fulfilling all of the following inclusion criteria are eligible for the study: * Adult patients (aged 55 years or older) * Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0 Exclusion Criteria: Participants meeting the following criteria are excluded from the study: * Delirium prior to ICU admission * Sleep disorder not caused by hypoactive delirium * Sedation in the ICU * Hypersensitivity to the studied substances (i.e., melatonin, placebo content) * Age \<55 years * Terminal state * Status epilepticus or postictal states following seizures on electroencephalogram (EEG) * Active psychosis * Substance abuse in current medical history * Dementia * Pregnancy

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Conditions

The condition(s) this trial relates to.

delirium

As listed by the trial registrant

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

Hypoactive 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

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

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