Actively Recruiting
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Led by New York State Psychiatric Institute · Updated on 2026-05-04
280
Participants Needed
7
Research Sites
354 weeks
Total Duration
On this page
Sponsors
N
New York State Psychiatric Institute
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia or schizoaffective disorder confirmed by Structured Clinical Interview for DSM-5
- Committed a minor or serious violent act in the last six months
- Willing and able to provide informed consent
- Medically stable as judged by the treating physician
- Suitable for treatment with clozapine or treatment as usual, including those currently medication-free or on antipsychotics other than clozapine or long-acting injectables with dosing intervals over 30 days
You will not qualify if you...
- Unstable or serious medical or neurological conditions, including bone marrow disorders
- History of intolerance or allergy to clozapine (e.g., agranulocytosis, bowel obstruction, myocarditis)
- History of intellectual impairment
- Pregnant or breastfeeding women, or women able to become pregnant not using effective birth control
- Recent high suicidal ideation or behavior, or judged too high risk for suicide for safe trial participation
- Documented intolerance or lack of benefit from a full trial of clozapine
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90024
Actively Recruiting
2
Augusta University Research Institute, Inc.
Augusta, Georgia, United States, 30912
Actively Recruiting
3
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
5
New York State Psychiatric Institute
New York, New York, United States, 10032
Actively Recruiting
6
Manhattan Psychiatric Center
New York, New York, United States, 10035
Actively Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
R
Ragy Girgis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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