What side effects are associated with this type of intervention?

Haloperidol, a dopamine receptor antagonist, can cause side effects such as extrapyramidal symptoms (e.g., tremors, rigidity), sedation, and in severe cases, neuroleptic malignant syndrome. It may also increase the risk of QT prolongation, leading to cardiac arrhythmias. Lorazepam, a GABA enhancer, is associated with sedation, dizziness, weakness, and potential dependency with long-term use. It can also cause respiratory depression, particularly in higher doses or when combined with other central nervous system depressants.

What prior FDA approvals exist?

Haloperidol, a dopamine receptor antagonist, has been widely used and is FDA-approved for the treatment of delirium, particularly in cases involving severe agitation and psychosis. Lorazepam, a benzodiazepine that enhances GABA activity, is also used off-label for delirium, especially when sedation is required. However, benzodiazepines are generally not the first line of treatment due to the risk of worsening delirium. Other antipsychotics like olanzapine and risperidone have also been used for managing delirium symptoms, although their use is often based on clinical practice rather than specific FDA approval for delirium.

What other types of research exist?

Promising novel alternatives to Haloperidol and Lorazepam for delirium treatment include investigational drugs like mGluR5 negative allosteric modulators (e.g., dipraglurant) and partial 5-HT1A/5-HT1B receptor agonists (e.g., eltoprazine). These drugs target different pathways and have shown potential in clinical trials for managing symptoms related to neuropsychiatric conditions.

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Antipsychotic

Haloperidol + Lorazepam for Cancer-related Delirium

Phase 2 & 3

Waitlist Available

Led By David Hui

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

Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)

Admitted to the acute palliative care unit

Must not have

History of myasthenia gravis or acute narrow angle glaucoma

History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-8 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing how well haloperidol and lorazepam help manage severe agitation and confusion in cancer patients receiving palliative care. These patients often do not respond to usual treatments. Haloperidol and lorazepam work by calming the brain and reducing symptoms of agitation and confusion.

Who is the study for?

This trial is for adults with advanced cancer experiencing persistent agitated delirium, despite treatment efforts. They must be admitted to a palliative care unit and have been on haloperidol or required it for agitation. Excluded are those with certain neurological disorders, history of severe reactions to the drugs being tested, or specific heart rhythm abnormalities.

What is being tested?

The study examines if haloperidol and lorazepam can effectively manage symptoms of agitated delirium in patients undergoing palliative care for advanced cancer. It also looks at how these medications might affect the well-being of caregivers.

What are the potential side effects?

Haloperidol may cause muscle stiffness, drowsiness, restlessness, and tremors. Lorazepam could lead to sedation, weakness, unsteadiness, memory issues or confusion. Both drugs carry a risk of worsening delirium in some cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced and cannot be cured with surgery or radiation.

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I am currently in a hospital's palliative care unit.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of myasthenia gravis or acute narrow angle glaucoma.

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I have had a seizure in the last week or a history of neuroleptic malignant syndrome.

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I have a history of Parkinson's, Alzheimer's, or Lewy body dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU)

Secondary study objectives

Delirium severity assessed using Memorial Delirium Assessment Scale

Delirium-related distress in caregivers and nurses assessed using Delirium Experience Questionnaire

Perceived comfort as assessed by caregivers and bedside nurses questionnaire

+6 more

Side effects data

From 2016 Phase 4 trial • 35 Patients • NCT02199743

21%

Insomnia

21%

Sedation

14%

Stiffness in jaw

diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

Lurasidone (LUR)

NONLUR

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group IV (placebo, lorazepam)Experimental Treatment4 Interventions

Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.

Group II: Group III (haloperidol, lorazepam)Experimental Treatment4 Interventions

Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.

Group III: Group II (lorazepam, placebo)Experimental Treatment4 Interventions

Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.

Group IV: Group I (haloperidol, placebo)Experimental Treatment4 Interventions

Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Haloperidol

FDA approved

Lorazepam

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Haloperidol, a dopamine receptor antagonist, works by blocking dopamine receptors in the brain, which helps reduce symptoms of delirium such as agitation and hallucinations caused by excessive dopamine activity. Lorazepam, a GABA enhancer, increases the activity of the calming neurotransmitter GABA, thereby reducing anxiety and agitation. These mechanisms are important as they guide clinicians in selecting treatments that target the specific neurochemical imbalances present in delirium, improving patient outcomes.