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

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Cancer Prevention Research Institute of Texas
• Treatments: Chlorpromazine; Haloperidol; Haloperidol decanoate; Valproic Acid

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 in the past 24 h requiring at least 1 dose of rescue medicationa

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)b

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 monthc

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 carbapenems, 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