Phenobarbital for Agitated Delirium
Key facts
- Who runs it
- Duke University
- Where
- Durham, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 3
- Started
- Jun 2026
- Expected to end
- Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Phenobarbital
- Conventional therapy group
- Record updated
- 6 November 2026
- Why it stopped
- Not approved by IRB
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Adult Patients identified by providers to have agitated or hyperactive delirium
Who cannot take part
- Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)
- Severe liver disease
- Pregnancy
- Incarceration
Where in United States
- Duke Regional HospitalDurham, United States
About the trial
What the trial wants to find out
The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit. Agitated delirium is a condition involving confusion and impulsiveness which is dangerous to both patients and healthcare providers.
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The main questions this trial aims to answer include:
* Can phenobarbital decrease the amount of time patients with agitated delirium spend in the intensive care unit and the hospital? * Does phenobarbital decrease the amount of additional calming medications patients with agitated delirium need?
Researchers in this study will compare phenobarbital to other medications commonly used to treat agitated delirium.
Participants will be monitored closely to make sure they remain safe and to measure how well their agitation and confusion are managed while they are in the ICU.
The 2 groups in the trial
- Phenobarbital TherapyTreatment being tested
In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Phenobarbital Therapy will receive this drug according to a validated protocol similar to that in use for patients with alcohol withdrawal. Additional "rescue" medications including dexmedetomidine will be available as needed.
Treatment: Phenobarbital
- Conventional TherapyExisting treatment, for comparison
In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Conventional Therapy will receive antipsychotics as the primary medications for managing their agitation. Additional "rescue" medications including antipsychotics and dexmedetomidine will be available as needed.
Treatment: Conventional therapy group
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 November 2026