NCT05208190 · New York State Psychiatric Institute
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
(REVISIT-C)
What this study is about
Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomly assigned in this 2-treatment group$1, parallel-group, 24-week, where both patients and doctors know the treatment given, 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
View original scientific 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 settings
Interventions
DRUG
Clozapine
treatment will occur naturalistically, as per standard clinical guidelines
DRUG
treatment as usual
naturalistic treatment with any other antipsychotic medication except clozapine
Primary outcome measures
Effectiveness outcome: Violent acts
Time frame: Time to violent act from randomization to treatment completion (24 weeks)
violent acts as measured by the MacArthur Community Violence Interview
Target engagement outcome: Excitement Factor of the Positive and Negative Syndrome Scale (PANSS)
Time frame: Randomization to end of study treatment (24 weeks)
a composite of the scores of excitement, uncooperativeness, poor impulse control, and hostility)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 myocardit
Where
- Los Angeles, California
- Augusta, Georgia
- Baltimore, Maryland
- New York, New York
- Chapel Hill, North Carolina
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations