Status:
RECRUITING
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cancer Prevention Research Institute of Texas
Conditions:
Delirium
Epileptics
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Objectives: Primary objective: Compare the effect of scheduled haloperidol, chlorpromazine, valproate and placebo (non-pharmacological interventions alone) on the frequency of breakthrough restlessn...
Eligibility Criteria
Inclusion
- \[Patients\] 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
Exclusion
- \[Patients\] 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
Key Trial Info
Start Date :
July 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05431595
Start Date
July 19 2022
End Date
February 2 2027
Last Update
November 18 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030