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

Launched by M.D. ANDERSON CANCER CENTER · Jun 20, 2022

Keywords

ClinConnect Summary

This clinical trial is researching how to best manage a condition called agitated delirium in hospitalized cancer patients. Agitated delirium can cause confusion and restlessness, making patients very uncomfortable. The study is comparing the effects of different medications, including haloperidol, chlorpromazine, and valproic acid, to see which works best when combined with standard non-drug treatments that help calm patients down. The goal is to find safer and more effective ways to relieve distress caused by delirium and improve quality of life for patients.

To be eligible for this trial, participants must be at least 18 years old, have advanced cancer, and show signs of delirium as defined by specific criteria. They also need to be seen by a palliative care team, which focuses on providing relief from the symptoms of serious illnesses. Participants will receive either one of the medications or a placebo (a treatment with no active ingredients) in a way that ensures neither the patient nor the doctors know which treatment is given, helping to keep the study unbiased. It's important for potential participants to discuss this opportunity with their healthcare team to see if it’s the right fit for them.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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