NIH-funded research R01 grant

Clozapine to reduce violence in schizophrenia

Official title: 1/7 Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

Funded at New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC · NIH-11411175 · Data updated 2026-11-12

A large study will compare clozapine to usual treatment to see if it lowers violent acts in people with schizophrenia who are at high risk of violence.

More Schizophrenia research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionNew York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC
NIH-funded
Lab location1 site (New York, United States)
Project startJuly 1, 2021
Project endJune 30, 2028
Funding year2026
Award (this year)$1,235,813
NIH project number5R01MH120317-04
Project IDNIH-11411175 on NIH RePORTER

Who could benefit from this research

Could help

Adults with schizophrenia who are at high risk for violence and can participate in outpatient care across multiple sites.

Less likely to help

Individuals without high violence risk or those unable to participate in outpatient follow-up may not benefit.

What this research studies

This trial tests whether clozapine can reduce violent behavior in community-dwelling adults with schizophrenia who are at high risk for violence. It is a 24-week, open-label study conducted at seven sites, coordinated by the New York State Psychiatric Institute, with a parallel-group design and a single rater. Participants will be randomly assigned to receive clozapine or treatment as usual, and the primary outcome is time to a violent act. The study aims to provide clearer evidence about clozapine’s effectiveness in real-world settings beyond hospital care. Outcomes will help guide clinicians on managing violence risk in schizophrenia patients in outpatient environments.

Why it matters

Potential benefit: If successful, the trial could lead to more effective strategies to reduce violence risk for people with schizophrenia and improve safety for patients and communities.

How similar studies have gone: Previous observational and small randomized studies suggested clozapine may reduce aggression, but this large, multicenter trial aims to provide more definitive evidence.

Where this research is happening

  • New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC
    New York, United States
    Active

Researchers

  • Principal investigator: Girgis, Ragy Ramsis — New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC
  • Study coordinator: Girgis, Ragy Ramsis

Related research

Other NIH-funded projects on the same topics.

  • Clozapine to reduce violent behavior in people with schizophrenia

    This compares clozapine with usual care to try to lower the chance of violent acts in people with schizophrenia who are at higher risk.

    NIH research University of California Los Angeles · Los Angeles, United States · NIH-11136416

  • Clozapine to Help Prevent Violence in Schizophrenia

    This project looks at whether a medication called clozapine can help people with schizophrenia reduce violent behavior.

    NIH research Augusta University · Augusta, United States · NIH-11135385

  • Clozapine to prevent violence in schizophrenia

    This project explores if a medication called clozapine can help reduce violent behavior in people living with schizophrenia.

    NIH research Univ of North Carolina Chapel Hill · Chapel Hill, United States · NIH-11134680

  • Clozapine to reduce violence in people with schizophrenia

    This trial will compare clozapine with usual antipsychotic care to see whether clozapine lowers the chance of violent acts in people with schizophrenia who are at high risk.

    NIH research University of Maryland Baltimore · Baltimore, United States · NIH-11134607

  • Clozapine to prevent violent behavior in people with schizophrenia

    This trial will compare clozapine with usual treatment to see if it lowers the chance of violent acts in people with schizophrenia who are at high risk.

    NIH research New York University School of Medicine · New York, United States · NIH-11134600

  • Clozapine to prevent violent behavior in people with schizophrenia

    This project compares clozapine to usual care to find out whether clozapine lowers the chance of violent acts in people with schizophrenia who are at higher risk.

    NIH research Nathan S. Kline Institute for Psych Res · Orangeburg, United States · NIH-11134582

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.