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
This is a single-blind, open-label, randomized, active comparator (TAU) controlled clinical trial to examine the effects of clozapine vs. TAU on the risk for violent acts as measured by the MacArthur Community Violence Interview (MCVI) and to examine the effects of clozapine vs. TAU on the Excitement Factor of the PANSS. Adults age 18-65 with schizophrenia or schizoaffective disorder who have committed a violent act within 6 months and are appropriate for treatment with clozapine or TAU will receive treatment for 24 weeks which will be naturalistically administered. Participants will also participate in assessments and appropriate medical monitoring which will include blood draws, pharmacokinetic blood samples, and physical exams, etc. Cox proportional hazards survival modeling will be used to test the association between treatment group and time until first violent act after randomization (i.e., number of weeks form randomization to violent act).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
treatment will occur naturalistically, as per standard clinical guidelines
naturalistic treatment with any other antipsychotic medication except clozapine
University of California, Los Angeles
Los Angeles, California, United States
RECRUITINGAugusta University Research Institute, Inc.
Augusta, Georgia, United States
RECRUITINGUniversity of Maryland School of Medicine
Baltimore, Maryland, United States
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)
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)
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)
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)
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NYU Langone Medical Center
New York, New York, United States
RECRUITINGNew York State Psychiatric Institute
New York, New York, United States
RECRUITINGManhattan Psychiatric Center
New York, New York, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITING