RecruitingPhase 2Phase 3NCT05431595

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

42 participants

Start Date

Jul 19, 2022

Study Type

INTERVENTIONAL

Conditions

Delirium Epileptics Neuroleptics

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

\[Patients\] 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 Criteria13

\[Patients\] 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