Biomarkers to Enhance Early Schizophrenia Treatment
Start Date
9/4/2024
Completion Date
7/30/2030
Summary
This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.
Detailed Description
The study is designed to test the hypothesis that, compared with standard treatment with FL-APs (risperidone or aripiprazole), early treatment with clozapine (CLZ) will benefit patients in the first episode of psychosis (FEP) who have been designated three biomarker positive (3B+) as follows: 1) likely to have a poor response to FL-APs; 2) not at heightened risk for clozapine-induced agranulocytosis and 3) not at heightened risk for antipsychotic-induced weight gain. The study will recruit n=410 FEP across the 5 participating sites for screening on each of the 3 biomarkers (striatal connectivity in relation to risk of treatment response/resistance to conventional antipsychotics, MC4R genotype in relation to weight gain risk, and HLA-DQB1 genotype in relation to agranulocytosis risk), which involves a rs-fMRI scan (for response/non-response prediction) and a blood draw for genotyping per above (to screen for heightened risk for each of the two side effects). Those failing to meet any of the 3 biomarker criteria will receive FEP care but will not be enrolled in the study.
Eligibility Criteria
Age Range: 18 years to 35 years
Interventions
aripiprazole
risperidone
clozapine
Conditions
Locations
The University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
University of California San Diego
La Jolla, California 92093
United States
McLean
Belmont, Massachusetts 02478
United States
Feinstein Institute for Medical Research
Glen Oaks, New York 11004
United States
Centre for Addiction and Mental Health
Toronto,
Canada