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

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Jan 12, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether clozapine, a specific medication used to treat schizophrenia, can help reduce the risk of violent behavior in individuals diagnosed with schizophrenia or schizoaffective disorder. The study will involve 280 participants who have shown recent violent behavior. They will be randomly assigned to receive either clozapine or standard antipsychotic treatment for 24 weeks to see which approach is more effective in preventing violence.

To be eligible for the trial, participants need to have a diagnosis of schizophrenia or schizoaffective disorder and must have acted violently in the last six months. They also need to be medically stable and able to give consent to participate. Throughout the study, participants will be monitored closely and will have access to medical care. It's important to know that certain individuals, such as those with serious medical conditions or a history of negative reactions to clozapine, will not be able to participate. This trial aims to gather valuable information that could improve treatment options for people with these mental health conditions.

Gender

ALL

Eligibility 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