Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy

NCT05431595 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0172NCI-2022-05252
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the effects of haloperidol, chlorpromazine, valproic acid and placebo, in conjunction with standardized non-pharmacologic interventions, in the first line treatment of agitated delirium in hospitalized patients with cancer. This double-blind, randomized clinical trial aims to provide evidence on various therapeutic options for palliating delirium, thereby reducing delirium-related distress and ultimately alleviating suffering.

Conditions

Delirium; Epileptics; Neuroleptics

Outcome Measures

Primary Outcomes (1)

• Edmonton Symptom Assessment Scale Questionnaire

  Edmonton Symptom Assessment Scale (ESAS)-score scale ranges from (0-10) No pain-0/Worse Possible Pain 10 (0-10)

  through study completion, an average of 1 year

Study Arms (4)

Group 1

EXPERIMENTAL

Participants will receive haloperidol by vein every 12 hours (or more often, as needed).

Drug: Haloperidol

Group 2

EXPERIMENTAL

Participants will receive chlorpromazine by vein every 12 hours (or more often, as needed).

Drug: Chlorpromazine

Group 3

EXPERIMENTAL

Participants will receive valproate by vein every 12 hours.

Drug: Valproate

Group 4

EXPERIMENTAL

Participants will receive placebo every by vein every 12 hours.

Drug: Placebo

Interventions

Haloperidol DRUG

Given by Vein (IV)

Group 1

Chlorpromazine DRUG

Given by Vein (IV)

Also known as: Chlorpromazine hydrochloride, Thorazine®

Group 2

Valproate DRUG

Given by Vein (IV)

Also known as: Depakene, Valproate Acid

Group 3

Placebo DRUG

Given by Vein (IV)

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
• \[Patients\] Seen by palliative care inpatient consultation team
• \[Patients\] Delirium as per DSM-5 criteria
• \[Patients\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium
• \[Patients\] Age 18 years or older
• \[Patients\] Permission from clinician from primary team to enroll
• \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
• \[Family Caregivers\] Age 18 years or older

You may not qualify if:

• \[Patients\] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d
• \[Patients\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
• \[Patients\] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month)
• \[Patients\] History of neuroleptic malignant syndrome as documented in chart
• \[Patients\] Active seizure disorder within past month as documented in chart
• \[Patients\] History of Parkinson's disease or dementia as documented in chart
• \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by most recent ECG within the past month
• \[Patients\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart
• \[Patients\] Pancreatitis within past month as documented in chart
• \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine
• \[Patients\] Physical signs of impending death such as respiration with mandibular movement and death rattle
• \[Patients\] Pregnancy as documented in chart
• \[Patients\] Active COVID-19 infection as documented in chart

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Delirium; Epilepsy

Interventions

Haloperidol; Chlorpromazine; Valproic Acid

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• David Hui, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hui, MD

CONTACT

(713) 792-6258; dhui@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 19, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)