Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNew York State Psychiatric Institute
About this 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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Clozapine
- treatment as usual
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
New York State Psychiatric Institute
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov