Back to search results

Clozapine for Preventing Violence in Schizophrenia

This study is looking at whether the medication clozapine can help reduce violent acts in people with schizophrenia or schizoaffective disorder. You might be able to join if you are between 18 and 65 years old, have one of these diagnoses, and have recently committed a violent act. Participants will receive either clozapine or another antipsychotic medication (treatment as usual) for 24 weeks. Researchers will measure how many violent acts occur during this time and also look at changes in excitement levels using a scale called PANSS. The study aims to enroll 280 people, but its current recruitment status is unclear.

Study design
This is an open-label, randomized study comparing clozapine to other antipsychotic treatments. It plans to include 280 participants.
What's involved
You would receive treatment for 24 weeks, which includes assessments, medical monitoring, blood draws, and physical exams.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured up to 24 weeks after randomization, which is the end of the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05208190

Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

Recruiting
PHASE4Ages 18–65InterventionalTreatment
New York State Psychiatric Institute
~280 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Clozapinetreatment as usual

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness outcome: Violent acts
Measured over Time to violent act from randomization to treatment completion (24 weeks)
+1 more outcome measured

Conditions

Schizophrenia
Schizoaffective Disorder

Explore related trials

Schizoaffective DisorderSchizophrenia

Where it's being run

7 sites across 5 states
New York3
California1
Georgia1
Maryland1
North Carolina1

Study leadership

  • Ragy Girgis, MD · PRINCIPAL_INVESTIGATOR · New York State Psychiatric Institute

Who to contact

Ragy Girgis
[email protected]
646-774-5553
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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

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

What this trial measures

  • Effectiveness outcome: Violent actsTime 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)Randomization to end of study treatment (24 weeks)

    a composite of the scores of excitement, uncooperativeness, poor impulse control, and hostility)