Can a common schizophrenia drug curb violent acts? new trial aims to find out
NCT ID NCT05208190
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether clozapine, a medication for schizophrenia, can reduce violent acts better than other antipsychotic drugs. Researchers will enroll 280 people with schizophrenia or schizoaffective disorder who have been violent in the past six months. Participants will receive either clozapine or their usual antipsychotic treatment for 24 weeks, and researchers will track violent behavior and other symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Clozapine (a medication also known as Clozaril)
- What this could lead to
- If it works, this could provide a clearer treatment option to reduce violence in people with schizophrenia, improving safety and quality of life.
- What could go wrong
- This is a Phase 4 trial, but results may not apply to everyone. Clozapine has known serious side effects, including blood disorders, and the open-label design may introduce bias.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5) * commission of a minor or serious act of violence as measured by the MCVI in the last six months * willing and able to provide informed consent * medically stable in judgment of physician providing study treatment * appropriate for treatment with either clozapine or TAU, i.e., that there is clinical equipoise between the two treatment options. Individuals who are currently medication free or on any antipsychotic, with the exception of clozapine or long-acting injectable medication with a dosing interval of more than 30 days will be eligible Exclusion Criteria: * An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow * A history of intolerance/allergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis) * A history of intellectual impairment * pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control * Individuals who score a 3, 4, or 5 within the previous month on the suicidal ideation section of the Columbia Suicide Severity Rating Scale (CSSRS), have any suicidal behavior (not including Not Suicidal Self Injury) within the previous 3 months, or are, in the opinion of the investigator, at too high of a risk for suicide to be safety treated in a randomized trial in which they may not be treated with clozapine * Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Augusta University Research Institute, Inc.
RECRUITINGAugusta, Georgia, 30912, United States
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Manhattan Psychiatric Center
RECRUITINGNew York, New York, 10035, United States
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NYU Langone Medical Center
RECRUITINGNew York, New York, 10016, United States
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New York State Psychiatric Institute
RECRUITINGNew York, New York, 10032, United States
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University of California, Los Angeles
RECRUITINGLos Angeles, California, 90024, United States
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University of Maryland School of Medicine
RECRUITINGBaltimore, Maryland, 21201, United States
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University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599, United States
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