Using clozapine to reduce violence in people with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves 280 adults aged 18-65 with schizophrenia or schizoaffective disorder who have a recent history of violent behavior. Participants will be randomly assigned to receive either clozapine or standard antipsychotic treatment for 24 weeks. The study aims to evaluate the effectiveness of clozapine in reducing the risk of future violent acts, using assessments such as the MacArthur Community Violence Interview. Participants will undergo medical monitoring, including blood tests and physical exams, throughout the trial.

Why it matters

Who can join: the full rules

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 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

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Augusta University Research Institute, Inc.
  Augusta, Georgia, United States Recruiting
• University of Maryland School of Medicine
  Baltimore, Maryland, United States Recruiting
• NYU Langone Medical Center
  New York, New York, United States Recruiting
• New York State Psychiatric Institute
  New York, New York, United States Recruiting
• Manhattan Psychiatric Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Ragy Girgis, MD — New York State Psychiatric Institute
• Study coordinator: Ragy Girgis
• Email: ragy.girgis@nyspi.columbia.edu
• Phone: 646-774-5553

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• State Representation in Early Psychosis 2

  This observational study tests how people with early psychosis and healthy individuals use state information during tasks and how brain activity supports it.

  Recruiting at 2 sites University of Minnesota · Minneapolis, Minnesota and 1 other locations · NCT07834203

• Trying the Kiso Mind smartphone app for people with schizophrenia spectrum disorders

  This study tests whether the Kiso Mind smartphone app is acceptable, practical, and helpful for adults with schizophrenia or schizoaffective disorder alongside their usual care.

  Recruiting Charite University, Berlin, Germany · Berlin, State of Berlin · NCT07395206

• Valbenazine for adults with tardive dyskinesia who remain symptomatic on or after a VMAT2 inhibitor

  This trial will test whether valbenazine reduces involuntary movements in adults with tardive dyskinesia who still have symptoms while taking or after stopping a VMAT2 inhibitor.

  Recruiting at 19 sites Phase 4 Neurocrine Biosciences · Bryant, Arkansas and 18 other locations · NCT07105111

• Using AI to Improve Rehabilitation for Patients with Severe Mental Disorders

  This study is testing if using AI and fun games can help people with severe mental disorders improve their social skills and get back into the community.

  Recruiting Shanghai Mental Health Center · Shanghai · NCT06904079

• Enhancing Veteran-Clinician Collaboration in VA Care for Serious Mental Illness

  This study tests a 10-session group program to help Veterans with serious mental illness collaborate better with their clinicians and care teams.

  Recruiting VA Office of Research and Development · San Diego, California and 2 other locations · NCT06898879

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.