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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Clozapine
Drugtreatment will occur naturalistically, as per standard clinical guidelines
treatment as usual
Drugnaturalistic treatment with any other antipsychotic medication except clozapine
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: ClozapineExperimental treatment 1 intervention
Group B: Treatment as usualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness outcome: Violent acts
violent acts as measured by the MacArthur Community Violence Interview
Time frame
Time to violent act from randomization to treatment completion (24 weeks)2
Target engagement outcome: Excitement Factor of the Positive and Negative Syndrome Scale (PANSS)
a composite of the scores of excitement, uncooperativeness, poor impulse control, and hostility)
Time frame
Randomization to end of study treatment (24 weeks)Secondary outcomes
1
Effect on aggression
examine the effects of clozapine vs TAU on aggression as measured by the Point Subtraction Aggression Paradigm
Time frame
Randomization to end of treatment (24 weeks)2
Positive symptoms and substance use
explore effects of clozapine vs TAU on the positive symptom sub scale of the PANSS and alcohol and illicit substance use, how these effects influence the risk for violent acts, and the degree to which clozapine's effects on the Excitement Factor of the PANSS are independent of its effects on total positive symptoms and substance use.
Time frame
Randomization to end of treatment (24 weeks)Other outcomes
1
Interventions to Prevent Violence
examine the effects of clozapine vs TAU on interventions to prevent violence based on a querying clinicians treating patients about interventions to prevent violence at weeks 4, 8, 16 and 24
Time frame
Randomization to end of treatment (24 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov