RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-19

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05431595

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

David Hui, MD

CONTACT

(713) 792-6258

dhui@mdanderson.org

Principal Investigator

David Hui, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2022-07-19

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Delirium
Epileptics
Neuroleptics