Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
Recruiting · NCT05431595 · Interventional (participants receive a specific treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
ChlorpromazineHaloperidolPlaceboValproate
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \[Patients\] 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 criteria
- \[Patients\] 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
Where it is running
1 location listed across 1 US state.
- MD Anderson Cancer Center - Houston, Texas, United States