Clinical trial for Delirium
Official title Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
ClinicalTrials.gov ID: NCT05431595
What this study is testing
What is Haloperidol?
An investigational IV medicine being studied as a potential treatment for agitated delirium in hospitalized cancer patients. is designed to block dopamine receptors in the brain, which may reduce agitation.
Also referred to as Haldol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study wants to find out which medicines are best for treating severe confusion and agitation in people with cancer.
- Who it's for
- The study is looking for hospitalized patients with cancer who are experiencing delirium (a state of confusion and agitation).
- What's involved
- Participants will receive one of four treatments: haloperidol, chlorpromazine, valproic acid, or a placebo (sugar pill), along with standard non-drug care.
- Time commitment
- The study involves a double-blind, randomized design where participants are assigned to a group, but the specific duration and visit schedule are not listed in the source text.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- [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.
- [Patients] Age 18 years or older
You likely can't join if
- [Patients] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d
- [Patients] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
- [Patients] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month)
- [Patients] History of neuroleptic malignant syndrome as documented in chart
- [Patients] Active seizure disorder within past month as documented in chart
- [Patients] History of Parkinson's disease or dementia as documented in chart
See the full eligibility criteria
- [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
- [Patients] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d
- [Patients] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
- [Patients] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month)
- [Patients] History of neuroleptic malignant syndrome as documented in chart
- [Patients] Active seizure disorder within past month as documented in chart
- [Patients] History of Parkinson's disease or dementia as documented in chart
- [Patients] History of prolonged QTc interval (\>500 ms) if documented by most recent ECG within the past month
- [Patients] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart
- [Patients] Pancreatitis within past month as documented in chart
- [Patients] Currently on lamotrigine, phenobarbital, or carbamazepine
- [Patients] Physical signs of impending death such as respiration with mandibular movement and death rattle
- [Patients] Pregnancy as documented in chart
- [Patients] Active COVID-19 infection as documented in chart
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.