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Old sedative drug could tame ICU delirium better than antipsychotics

NCT ID NCT07548489

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether phenobarbital, an older sedative, can safely calm agitated delirium in ICU patients as well as standard antipsychotics. About 150 adults with hyperactive delirium will receive either phenobarbital or usual care. Researchers will compare how long patients stay in the ICU and hospital, and whether they need extra calming medications.

What this could mean

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

Active substance
Phenobarbital
What this could lead to
If it works, this could offer a simpler, possibly safer option to calm agitated ICU patients, potentially shortening their hospital stay.
What could go wrong
This is an early-stage Phase 3 trial with only 150 participants. Phenobarbital may not work better than current drugs and carries risks like sedation or breathing problems.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

21 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: * Adult Patients identified by providers to have agitated or hyperactive delirium Exclusion Criteria: * Pregnancy * Incarceration * Severe liver disease * Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)

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Conditions

The condition(s) this trial relates to.

Confusion delirium

As listed by the trial registrant

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

Agitated delirium Delirium confusional state Delirium in the intensive care unit Hyperactive 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

  • Duke Regional Hospital

    Durham, North Carolina, 27704, United States

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