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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have delirium and need medication or special care for agitation.
Select...
My cancer is advanced and cannot be cured with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Edmonton Symptom Assessment Scale Questionnaire
Side effects data
From 2016 Phase 4 trial • 35 Patients • NCT0219974321%
Sedation
21%
Insomnia
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
Chlorpromazine
2010
Completed Phase 4
~930
Valproate
2021
Completed Phase 4
~2940
Placebo
1995
Completed Phase 3
~2670
Haloperidol
2013
Completed Phase 4
~1238310
Find a Location
Who is running the clinical trial?
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,288 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,652 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking more than 4 mg of haloperidol, 100 mg of chlorpromazine, or 750 mg of valproate daily.You are pregnant, as shown in your medical records.I am currently taking lamotrigine, phenobarbital, or carbamazepine.I have been seen by a palliative care team in the hospital.I have a documented history of Parkinson's disease or dementia.I have a history of myasthenia gravis, glaucoma, or liver-related brain issues.I am not showing signs of being near death.I have a documented history of neuroleptic malignant syndrome.My liver tests are within normal limits in the past month.I have had a seizure in the last month.I have had pancreatitis in the last month.Your heart's electrical activity was abnormal in the past month.I am 18 years old or older.I have delirium and need medication or special care for agitation.My cancer is advanced and cannot be cured with surgery or radiation.You have symptoms of confusion and disorientation according to specific medical guidelines.Your spouse, adult child, sibling, parent, other relative, or significant other (as defined by you)You currently have a documented case of COVID-19.You have a documented allergy to haloperidol, chlorpromazine, or valproate.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4
- Group 2: Group 3
- Group 3: Group 1
- Group 4: Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrollees needed for this research project?
"Yes, the information on clinicaltrials.gov indicates that this clinical trial is actively looking for participants. The clinical trial was initially posted on December 30th, 2022 and was most recently updated on July 20th, 2022. The clinical trial is searching for 150 participants between 1 and 100 years old at 1 site."
Answered by AI
How many individuals are currently a part of this research project?
"That is correct, the online posting for this clinical trial on clinicaltrials.gov shows that the research is actively recruiting subjects. The listing was first posted on December 30th, 2020 and was last updated on July 20th, 2020. The study is looking to enroll 150 individuals at a single research site."
Answered by AI
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