NCT05431595RecruitingPhase 2/3
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 20 Jun 2022
- Start date
- 19 Jul 2022
- Primary completion date
- 2 Feb 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Epilepsy
- NCT number
- NCT05431595
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 42
- From 19 Jul 2022 to the primary completion date, 2 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine
Other illness
- \[Patients\] 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
Lab values
- \[Patients\] 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
Other
- \[Patients\] 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
Who the study is looking for
- \[Patients\] 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.