Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- Haloperidol (drug)
- Chlorpromazine (drug)
- Valproate (drug)
- Placebo (drug)
Sponsor: M.D. Anderson Cancer Center · Participants: 42 · Started: Jul 19, 2022
Contact the study team
- David Hui, MD · Phone: (713) 792-6258
Official record on ClinicalTrials.gov — NCT05431595
Locations in the U.S.
| Texas | MD Anderson Cancer Center, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.