Recruiting PHASE2, PHASE3 Delirium

New treatment option 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?

Haloperidol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for delirium.

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: 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.

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. sitter, restraints) for...
[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

Who can join

[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

What rules you out

[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's taking place

Houston, Texas, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

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 - 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?

Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.