RecruitingPhase 4NCT05208190

Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial


Sponsor

New York State Psychiatric Institute

Enrollment

280 participants

Start Date

Mar 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether clozapine, an antipsychotic medication, is more effective than other standard psychiatric medications at reducing violent behavior in people with schizophrenia or schizoaffective disorder. Clozapine has been used for decades but this trial specifically examines its potential to prevent violence. **You may be eligible if...** - You have a diagnosis of schizophrenia or schizoaffective disorder - You have committed a minor or serious act of violence in the last 6 months - You are medically stable - You are willing and able to provide informed consent - Both clozapine and standard treatment are considered medically appropriate options for you **You may NOT be eligible if...** - You have an unstable or serious medical condition affecting the bone marrow - You have a history of serious reactions to clozapine (such as dangerous low white blood cell counts, bowel obstruction, or heart inflammation) - You have an intellectual disability - You are pregnant, breastfeeding, or unwilling to use birth control - You have a high and immediate risk of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClozapine

treatment will occur naturalistically, as per standard clinical guidelines

DRUGtreatment as usual

naturalistic treatment with any other antipsychotic medication except clozapine


Locations(7)

University of California, Los Angeles

Los Angeles, California, United States

Augusta University Research Institute, Inc.

Augusta, Georgia, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

NYU Langone Medical Center

New York, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Manhattan Psychiatric Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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NCT05208190


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