Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT05431595

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

Led by M.D. Anderson Cancer Center · Updated on 2025-11-18

42

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

C

Cancer Prevention Research Institute of Texas

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of advanced cancer (locally advanced, metastatic, recurrent, or incurable)
  • Seen by palliative care inpatient consultation team
  • Diagnosis of delirium according to DSM-5 criteria
  • Hyperactive or mixed delirium with rescue medication order or non-pharmacologic measures for agitation, restlessness, or delirium
  • Age 18 years or older
  • Permission from primary team clinician to enroll
  • Family caregivers are spouse, adult child, sibling, parent, other relative, or significant other defined by the patient
  • Family caregivers age 18 years or older
Not Eligible

You will not qualify if you...

  • Scheduled haloperidol dose >4 mg/day, chlorpromazine >100 mg/day, or valproate >750 mg/day
  • History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy
  • Hepatic dysfunction with unresolved AST or ALT >2.5 times upper limit, bilirubin >1.5 times upper limit, or INR >1.5 within past month
  • History of neuroleptic malignant syndrome
  • Active seizure disorder within past month
  • History of Parkinson's disease or dementia
  • History of prolonged QTc interval >500 ms on recent ECG within past month
  • Hypersensitivity to haloperidol, chlorpromazine, or valproate
  • Pancreatitis within past month
  • Current use of lamotrigine, phenobarbital, or carbamazepine
  • Physical signs of impending death such as respiration with mandibular movement and death rattle
  • Pregnancy
  • Active COVID-19 infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

David Hui, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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