Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
New York State Psychiatric Institute
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
Description
This is a single-blind, open-label, randomized, active comparator (TAU) controlled clinical trial to examine the effects of clozapine vs. TAU on the risk for violent acts as measured by the MacArthur Community Violence Interview (MCVI) and to examine the effects of clozapine vs. TAU on the Excitement Factor of the PANSS. Adults age 18-65 with schizophrenia or schizoaffective disorder who have committed a violent act within 6 months and are appropriate for treatment with clozapine or TAU will receive treatment for 24 weeks which will be naturalistically administered. Participants will also part…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugClozapine
treatment will occur naturalistically, as per standard clinical guidelines
- Drugtreatment as usual
naturalistic treatment with any other antipsychotic medication except clozapine
Locations (7)
- University of California, Los AngelesLos Angeles, California
- Augusta University Research Institute, Inc.Augusta, Georgia
- University of Maryland School of MedicineBaltimore, Maryland
- NYU Langone Medical CenterNew York, New York
- New York State Psychiatric InstituteNew York, New York
- Manhattan Psychiatric CenterNew York, New York