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 risk of violent acts in real-world settings.

Study Length

24 weeks

Disorder/Condition

Schizophrenia

Inclusion Criteria

  • DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Committed a minor or serious act of violence as measured by the MCVI in the last six months
  • 18 to 65 years old
  • Appropriate for treatment with either clozapine or TAU

Study Title (brief)

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

Study Description (brief)

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.

Study Contact

For more information about this study, please contact Seth Eaton, research coordinator, at 646-766-5864 or Seth.Eaton@omh.ny.gov.

Exclusion Criteria

  • An unstable or serious medical or neurological condition
  • A history of intolerance/allergy to clozapine
  • A history of intellectual impairment
  • Pregnant or lactating women; women who are able to become pregnant but who are not willing to use effective methods of birth control.

Study Location

Manhattan Psychiatric Center, 102 Rivers Edge Road, New York, NY 10035 AND Manhattan Psychiatric Center Outpatient Clinic, 163 West 125th Street, New York, NY 10027