Comparing Clozapine and Usual Antipsychotic Treatment to Reduce Violence in Adults with Schizophrenia or Schizoaffective Disorder

What this Trial Is About

Researchers are evaluating treatment options for adults aged 18 to 65 with schizophrenia or schizoaffective disorder who have recently committed violent acts. This randomized clinical trial aims to compare the effects of clozapine versus antipsychotic treatment as usual TAU on reducing the risk of violent behavior and on excitement symptoms. The study is open-label and single-blind, conducted across seven sites, and sponsored by the New York State Psychiatric Institute. Participants will be randomly assigned to receive either clozapine, administered naturally according to clinical guidelines, or treatment as usual with any antipsychotic medication other than clozapine. The treatment period lasts for 24 weeks, during which medications are given in real-world settings. The trial includes two main groups one receiving clozapine and the other receiving the usual antipsychotic treatment. Over the 24-week study, participants will undergo various assessments including blood draws, pharmacokinetic blood sampling, physical exams, and clinical interviews. Researchers will measure the time to any violent act after starting treatment using the MacArthur Community Violence Interview and evaluate excitement levels with the Positive and Negative Syndrome Scale PANSS. Safety monitoring and medical evaluations will continue throughout, with the main focus on violent behavior reduction and symptom changes during the treatment period.

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