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

NCT05431595 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Delirium
  • Epileptics
  • Neuroleptics

Interventions

DRUG

Haloperidol

Given by Vein (IV)

DRUG

Chlorpromazine

Given by Vein (IV)

DRUG

Valproate

Given by Vein (IV)

DRUG

Placebo

Given by Vein (IV)

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Hui, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2027-02-02
Completion
2027-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05431595 on ClinicalTrials.gov