Clozapine to reduce violence in people with schizophrenia
Official title: 4/7 Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Funded at University of Maryland Baltimore · NIH-11134607 · Data updated 2026-11-12
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.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Maryland Baltimore NIH-funded |
| Lab location | 1 site (Baltimore, United States) |
| Project start | July 1, 2021 |
| Project end | June 30, 2027 |
| Funding year | 2025 |
| Award (this year) | $193,125 |
| NIH project number | 5R01MH120354-05 |
| Project ID | NIH-11134607 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults diagnosed with schizophrenia who are considered at high risk for violent behavior and who can comply with clozapine's required blood monitoring are the best fit.
✕Less likely to help
People without schizophrenia, those not judged to be at elevated risk for violence, or anyone with medical contraindications to clozapine (for example low white blood cell counts, inability to comply with blood monitoring, or pregnancy) are unlikely to benefit.
What this research studies
If you join, you'll be randomly assigned to receive clozapine or your usual antipsychotic treatment for 24 weeks. The trial is open-label so your treating clinicians will know your medication, but the people who rate outcomes will be blinded. About 280 adults with schizophrenia judged to be at high risk for violence will be enrolled across seven community sites coordinated by the New York State Psychiatric Institute and led by the University of Maryland Baltimore. The study will track violent acts and safety measures, including regular blood tests required for clozapine.
Why it matters
Potential benefit: If successful, this could lower violent behavior and improve safety, clinical outcomes, and stigma for people with schizophrenia.
How similar studies have gone: Smaller and mostly observational studies have suggested clozapine reduces aggression, but large randomized effectiveness trials in community outpatient settings have not previously answered this question.
Where this research is happening
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University of Maryland Baltimore
Baltimore, United States Active
Researchers
- Principal investigator: Kelly, Deanna L — University of Maryland Baltimore
- Study coordinator: Kelly, Deanna L
Related research
Other NIH-funded projects on the same topics.
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Clozapine to reduce violence in schizophrenia
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.
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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.
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Clozapine to Help Prevent Violence in Schizophrenia
This project looks at whether a medication called clozapine can help people with schizophrenia reduce violent behavior.
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Clozapine to prevent violence in schizophrenia
This project explores if a medication called clozapine can help reduce violent behavior in people living with schizophrenia.
-
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.
-
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.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.