Recruiting
Phase 2
Phase 3

Neuroleptics & Anti-Epileptics

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05431595

Conditions

Delirium

Epileptics

Neuroleptics

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Haloperidol

Chlorpromazine

Valproate

Placebo

Study Details

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

Study ID

NCT05431595

Start date

Jul 19, 2022

Status verified date

Nov, 2025

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group 1

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

experimental: Group 2

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

experimental: Group 3

Participants will receive valproate by vein every 12 hours.

experimental: Group 4

Participants will receive placebo every by vein every 12 hours.

Interventions

Haloperidol

Given by Vein (IV)

Chlorpromazine

Given by Vein (IV)

Valproate

Given by Vein (IV)

Placebo

Given by Vein (IV)

Primary outcome measure

  • Edmonton Symptom Assessment Scale Questionnaire [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

David Hui, MD

(713) 792-6258dhui@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

David Hui, MD

713-792-6258dhui@mdanderson.org

Principal Investigator:

David Hui, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2025-11-18.