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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05431595
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Delirium
  • Epileptics
  • Neuroleptics

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Haloperidol — DRUG
    Given by Vein (IV)
  • Chlorpromazine — DRUG
    Given by Vein (IV)
  • Valproate — DRUG
    Given by Vein (IV)
  • Placebo — DRUG
    Given by Vein (IV)

Study Details

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.

Key Dates

Start date
Jul 19, 2022
Status verified
Nov 2025
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group 1
    Participants will receive haloperidol by vein every 12 hours (or more often, as needed).
  • Experimental: Group 2
    Participants will receive chlorpromazine by vein every 12 hours (or more often, as needed).
  • Experimental: Group 3
    Participants will receive valproate by vein every 12 hours.
  • Experimental: Group 4
    Participants will receive placebo every by vein every 12 hours.

Primary Outcome Measure

Edmonton Symptom Assessment Scale Questionnaire [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
David Hui, MD
[email protected]
713-792-6258
David Hui, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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