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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Delirium, Epileptics, Neuroleptics

In brief

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.

Key facts

Study ID

NCT05431595

Run by

M.D. Anderson Cancer Center

People needed

42

Starts

2022-07-19

Expected to finish

2027-02-02

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• [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

You may not qualify if…

• [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

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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