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Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
NCT05208190 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG Clozapine
- DRUG treatment as usual
Study Locations (7)
New York
- NYU Langone Medical Center — New York
- New York State Psychiatric Institute — New York
- Manhattan Psychiatric Center — New York
California
- University of California, Los Angeles — Los Angeles
Georgia
- Augusta University Research Institute, Inc. — Augusta
Maryland
- University of Maryland School of Medicine — Baltimore
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2022-03-17 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05208190
The ClinicalTrials.gov registry entry for NCT05208190 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions — of which Clozapine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05208190 reports 7 study locations spanning 5 distinct geographic areas — top geographies include New York, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05208190 about?
NCT05208190 is a clinical study titled "Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial". 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 r...
What is the current status of trial NCT05208190?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 280 participants. The study started on 2022-03-17. Estimated completion is 2028-12-31.
What conditions does trial NCT05208190 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05208190?
The interventions under investigation include: Clozapine (DRUG), treatment as usual (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05208190?
This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05208190 being conducted?
This trial has 7 study locations across California, Georgia, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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