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RecruitingAccepts healthy volunteersPhase 2/Phase 3

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

M.D. Anderson Cancer Center · with Cancer Prevention Research Institute of Texas · NCT05431595

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
42
US sites recruiting
1
Study start
July 19, 2022
Record last updated
November 18, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Haloperidol; Chlorpromazine; Valproate; Placebo

Conditions: Delirium; Epileptics; Neuroleptics

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • [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

Exclusion Criteria

  • [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

Recruiting US locations

  • MD Anderson Cancer Center

    Houston, TX 77030

    Site contact: David Hui, MD · 713-792-6258 · dhui@mdanderson.org

Study contacts (from the official record)

  • David Hui, MD · (713) 792-6258 · dhui@mdanderson.org
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Managing Agitated Delirium With Neuroleptics and Anti-Epileptics… (NCT05431595) | Bored Studies