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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \[Patients\] 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

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
David Hui, MD
dhui@mdanderson.org
(713) 792-6258
Time Frame
Start Date: 2022-07-19
Estimated Completion Date: 2027-02-02
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Cancer Prevention Research Institute of Texas

This content was sourced from clinicaltrials.gov