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Antipsychotic

Neuroleptics + Anti-Epileptics for Delirium

Phase 2 & 3
Waitlist Available
Led By David Hui, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium
Must not have
On scheduled haloperidol >4 mg/d, chlorpromazine >100 mg/d, or valproate >750 mg/d
Currently on lamotrigine, phenobarbital, or carbamazepine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year

Summary

This trial is examining the effects of different drugs in conjunction with standardized non-pharmacologic interventions to treat agitated delirium in cancer patients.

Who is the study for?
This trial is for adults with advanced cancer experiencing agitated delirium. They must be seen by a palliative care team and have permission from their primary clinician to enroll. Exclusions include certain pre-existing conditions like myasthenia gravis, glaucoma, or hepatic encephalopathy; high doses of specific medications; active seizure disorders; Parkinson's disease or dementia; pregnancy; COVID-19 infection; and hypersensitivity to the drugs being tested.
What is being tested?
The study tests haloperidol, chlorpromazine, valproic acid (an anti-epileptic), and placebo in treating agitated delirium in hospitalized cancer patients. It's a double-blind trial where neither doctors nor patients know who gets which treatment, aiming to find better ways to ease delirium-related distress without over-relying on neuroleptics.
What are the potential side effects?
Possible side effects may include sedation, dizziness, upset stomach, changes in blood pressure or heart rhythm disturbances due to haloperidol or chlorpromazine. Valproate can cause liver issues, tremors, hair loss or mood swings. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have delirium and need medication or special care for agitation.
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My cancer is advanced and cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking more than 4 mg of haloperidol, 100 mg of chlorpromazine, or 750 mg of valproate daily.
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I am currently taking lamotrigine, phenobarbital, or carbamazepine.
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I have a documented history of Parkinson's disease or dementia.
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I have a history of myasthenia gravis, glaucoma, or liver-related brain issues.
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I am not showing signs of being near death.
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I have a documented history of neuroleptic malignant syndrome.
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My liver tests are within normal limits in the past month.
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I have had a seizure in the last month.
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I have had pancreatitis in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Edmonton Symptom Assessment Scale Questionnaire

Side effects data

From 2016 Phase 4 trial • 35 Patients • NCT02199743
21%
Insomnia
21%
Sedation
14%
Stiffness in jaw
7%
diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lurasidone (LUR)
NONLUR

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Participants will receive placebo every by vein every 12 hours.
Group II: Group 3Experimental Treatment1 Intervention
Participants will receive valproate by vein every 12 hours.
Group III: Group 2Experimental Treatment1 Intervention
Participants will receive chlorpromazine by vein every 12 hours (or more often, as needed).
Group IV: Group 1Experimental Treatment1 Intervention
Participants will receive haloperidol by vein every 12 hours (or more often, as needed).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Chlorpromazine
2010
Completed Phase 4
~930
Valproate
2021
Completed Phase 4
~2940
Haloperidol
2013
Completed Phase 4
~1238310

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
53 Previous Clinical Trials
99,033 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,234 Total Patients Enrolled
6 Trials studying Delirium
598 Patients Enrolled for Delirium
David Hui, MDPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
101,390 Total Patients Enrolled
1 Trials studying Delirium
93 Patients Enrolled for Delirium

Media Library

Chlorpromazine (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05431595 — Phase 2 & 3
Delirium Research Study Groups: Group 4, Group 3, Group 1, Group 2
Delirium Clinical Trial 2023: Chlorpromazine Highlights & Side Effects. Trial Name: NCT05431595 — Phase 2 & 3
Chlorpromazine (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05431595 — Phase 2 & 3
~5 spots leftby Feb 2027
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