Clozapine Compared With Usual Care to Reduce Violence in Schizophrenia
Compares clozapine with usual antipsychotic treatment in people with schizophrenia who recently acted violently.
Plain-language title generated from the registry record
Registry title: Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Key facts
- Where
- Augusta, Baltimore, Chapel Hill, Los Angeles, and New York, United StatesSee the 7 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05208190, who can take part
Where in United States
- Augusta University Research Institute, Inc.Augusta, United StatesTaking people
- University of Maryland School of MedicineBaltimore, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Manhattan Psychiatric CenterNew York, United StatesTaking people
- New York State Psychiatric InstituteNew York, United StatesTaking people
- NYU Langone Medical CenterNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- New York State Psychiatric Institute
- Trial code
- NCT05208190
- Record updated
- 4 May 2026
- Original description
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 settingsRead full original descriptionShow less
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
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
Inclusion: 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: 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; 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; Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial.