Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
NCT ID: NCT05208190
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
280 participants
INTERVENTIONAL
2022-03-17
2028-12-31
Brief Summary
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Detailed Description
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The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. (The IO in concurrence with the IRB paused human subjects research on June 12, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.) Therefore, the NYSPI site is not enrolling at this time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Clozapine
treatment with clozapine naturalistically administered (as per clinical guideline).
Clozapine
treatment will occur naturalistically, as per standard clinical guidelines
Treatment as usual
open label naturalistic treatment as usual with any antipsychotic other than clozapine
treatment as usual
naturalistic treatment with any other antipsychotic medication except clozapine
Interventions
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Clozapine
treatment will occur naturalistically, as per standard clinical guidelines
treatment as usual
naturalistic treatment with any other antipsychotic medication except clozapine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Ragy Girgis
Professor of Clinical Psychiatry
Principal Investigators
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Ragy Girgis, MD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I20-02054
Identifier Type: -
Identifier Source: org_study_id
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