Testing Medicines for Agitation in Hospitalized Patients With Cancer
Compares haloperidol, chlorpromazine, valproate and placebo for agitated delirium in hospitalized adults with cancer.
Plain-language title generated from the registry record
Registry title: Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 2/3
Where in United States
- MD Anderson Cancer CenterHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- M.D. Anderson Cancer Center
- Trial code
- NCT05431595
- Record updated
- 18 November 2025
- Original description
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.Read full original descriptionShow less
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
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.
Inclusion: [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: [Patients] Currently on lamotrigine, phenobarbital, or carbamazepine; [Patients] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart; [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] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart; [Patients] Active COVID-19 infection 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 prolonged QTc interval (>500 ms) if documented by most recent ECG within the past month; [Patients] On scheduled haloperidol >4 mg/d, chlorpromazine >100 mg/d, or valproate >750 mg/d; [Patients] Pancreatitis within past month as documented in chart; [Patients] Physical signs of impending death such as respiration with mandibular movement and death rattle; [Patients] Pregnancy as documented in chart.