Project Grant R01MH134901

This Project Grant award from the National Institute of Mental Health (NIMH) under the Mental Health Research Grants program (CFDA 93.242) is for a multi-center, randomized clinical trial to evaluate the use of biomarkers to improve treatment decisions for patients experiencing their first episode of psychosis (FEP). The $795,000 award to the University of California, San Diego (UC San Diego) aims to develop a "Clozapine Decision Support Tool" that leverages three specific biomarkers - a functional brain scan, a genetic test for weight gain risk, and a genetic test for agranulocytosis risk - to guide the use of the antipsychotic medication clozapine for FEP patients at risk of poor response to first-line antipsychotics. The 5-year project will characterize 410 FEP patients using the biomarkers and then randomize a subset (approximately 180) who are predicted to not respond well to first-line antipsychotics but have low risk of severe side effects to receive either clozapine or a first-line antipsychotic. The primary outcomes will evaluate clinical response, including positive symptoms, suicidal thinking, and hospitalization days. The project also includes collaboration with individuals with lived experience of psychosis and their family members to inform the study design and outcomes.