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

NCT05208190 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-05-04

No results posted yet for this 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

Interventions

DRUG

Clozapine

treatment will occur naturalistically, as per standard clinical guidelines

DRUG

treatment as usual

naturalistic treatment with any other antipsychotic medication except clozapine

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Ragy Girgis, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05208190 on ClinicalTrials.gov