NCT05208190

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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). The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. (The IO in concurrence with the IRB paused human subjects research on June 12, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.) Therefore, the NYSPI site is not enrolling at this time.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Clozapine	treatment will occur naturalistically, as per standard clinical guidelines
DRUG	treatment as usual	naturalistic treatment with any other antipsychotic medication except clozapine

Timeline

• Start date: 2022-03-17
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2022-01-26
• Last updated: 2026-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study