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

• Status: Not yet recruiting
• Trial end date: 2027-02-28
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Clozapine

Criteria

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 the exception of clozapine or long-acting injectable medication with a dosing interval of more than 30 days will be eligible

Exclusion Criteria:

• An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow

• A history of intolerance/allergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)

• A history of intellectual impairment

• pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control

• Individuals who score a 3, 4, or 5 within the previous month on the suicidal ideation section of the Columbia Suicide Severity Rating Scale (CSSRS), have any suicidal behavior (not including Not Suicidal Self Injury) within the previous 3 months, or are, in the opinion of the investigator, at too high of a risk for suicide to be safety treated in a randomized trial in which they may not be treated with clozapine

• Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial