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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Delirium
Epileptics
Neuroleptics

Treatments

Drug: Valproate
Drug: Placebo
Drug: Chlorpromazine
Drug: Haloperidol

Study type

Interventional

Funder types

Other

Identifiers

NCT05431595
2022-0172
NCI-2022-05252 (Other Identifier)

Details and patient eligibility

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.

Full description

Objectives:

Primary objective:

Compare the effect of scheduled haloperidol, chlorpromazine, valproate and placebo (non-pharmacological interventions alone) on the frequency of breakthrough restlessness over 72 hours in patients with agitated delirium seen by the palliative care consultation team. Our working hypothesis is that haloperidol, chlorpromazine, and valproate will lead to fewer episodes of breakthrough restlessness than placebo.

Secondary Objective #1:

Compare the effects of scheduled haloperidol, chlorpromazine, valproate and placebo on (1) RASS-PAL, (2) need for dose escalation, (3) perceived comfort by caregivers and bedside nurses, (4) delirium severity (Memorial Delirium Assessment Scale), (5) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire), (6) delirium recall in patients (Delirium Recall Questionnaire), (7) symptom expression (Edmonton Symptom Assessment Scale), (8) adverse effects, and (9) survival. Our working hypothesis is that haloperidol, chlorpromazine, and valproate are superior to placebo (non-pharmacologic interventions alone) in improving delirium-related outcomes.

Secondary Objective #2:

Estimate the efficacy of non-pharmacologic interventions alone on breakthrough restlessness. Our working hypothesis is that patients in the placebo group will require fewer breakthrough doses in the 72 hours after implementation of non-pharmacological interventions

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 4 patient groups

Group 1
Experimental group
Description:
Participants will receive haloperidol by vein every 12 hours (or more often, as needed).
Treatment:
Drug: Haloperidol
Group 2
Experimental group
Description:
Participants will receive chlorpromazine by vein every 12 hours (or more often, as needed).
Treatment:
Drug: Chlorpromazine
Group 3
Experimental group
Description:
Participants will receive valproate by vein every 12 hours.
Treatment:
Drug: Valproate
Group 4
Experimental group
Description:
Participants will receive placebo every by vein every 12 hours.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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