RECRUITING

Managing Agitated Delirium with Neuroleptics and Anti-Epileptics As a Neuroleptic Sparing Strategy

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.

Conditions

DeliriumEpilepticsNeuroleptics
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Related Conditions:

DeliriumEpilepticsNeuroleptics

Study Overview

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Study Details

Study overview

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.

Managing Agitated Delirium with Neuroleptics and Anti-Epileptics As a Neuroleptic Sparing Strategy

Managing Agitated Delirium with Neuroleptics and Anti-Epileptics As a Neuroleptic Sparing Strategy

Condition
Delirium
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
  • 2. \[Patients\] Seen by palliative care inpatient consultation team
  • 3. \[Patients\] Delirium as per DSM-5 criteria
  • 4. \[Patients\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium
  • 5. \[Patients\] Age 18 years or older
  • 6. \[Patients\] Permission from clinician from primary team to enroll
  • 7. \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
  • 8. \[Family Caregivers\] Age 18 years or older
  • 1. \[Patients\] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d
  • 2. \[Patients\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
  • 3. \[Patients\] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month)
  • 4. \[Patients\] History of neuroleptic malignant syndrome as documented in chart
  • 5. \[Patients\] Active seizure disorder within past month as documented in chart
  • 6. \[Patients\] History of Parkinson's disease or dementia as documented in chart
  • 7. \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by most recent ECG within the past month
  • 8. \[Patients\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart
  • 9. \[Patients\] Pancreatitis within past month as documented in chart
  • 10. \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine
  • 11. \[Patients\] Physical signs of impending death such as respiration with mandibular movement and death rattle
  • 12. \[Patients\] Pregnancy as documented in chart
  • 13. \[Patients\] Active COVID-19 infection as documented in chart

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

M.D. Anderson Cancer Center,

David Hui, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2027-02-02