Phenobarbital for Agitated Delirium

NCT07548489 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: Pro00119911
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Agitated Delirium; Delirium Confusional State; Delirium in the Intensive Care Unit; Hyperactive Delirium

Outcome Measures

Primary Outcomes (1)

• Provider Compliance

  The primary outcome of this study will be provider compliance with the study protocol assessed by selection of Conventional or Phenobarbital Therapy according to the designated month.

  Six months

Secondary Outcomes (3)

• Hospital Length of Stay

  Six months

• ICU Length of Stay

  Six months

• Need for rescue medications

  Six months

Study Arms (2)

Phenobarbital Therapy

EXPERIMENTAL

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.

Drug: Phenobarbital

Conventional Therapy

ACTIVE COMPARATOR

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.

Drug: Conventional therapy group

Interventions

Phenobarbital DRUG

Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.

Phenobarbital Therapy

Conventional therapy group DRUG

Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.

Conventional Therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients identified by providers to have agitated or hyperactive delirium

You may not qualify if:

• Pregnancy
• Incarceration
• Severe liver disease
• Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

Related Publications (1)

• Malone D, Costin BN, MacElroy D, Al-Hegelan M, Thompson J, Bronshteyn Y. Phenobarbital versus benzodiazepines in alcohol withdrawal syndrome. Neuropsychopharmacol Rep. 2023 Dec;43(4):532-541. doi: 10.1002/npr2.12347. Epub 2023 Jun 27.

  PMID: 37368937 BACKGROUND

MeSH Terms

Conditions

Confusion

Interventions

Phenobarbital

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Keith W. Van Dusen, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith W Van Dusen, M.D.

CONTACT

(919) 684-8111; kwv@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Following completion of the study (Estimated late 2027), for 1 year.
• Access Criteria: Only researchers who request IPD data and are approved by the DUH IRB to access will be permitted to review IPD data.

Locations

US (1)