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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
aripiprazole arm (titrated dose)
risperidone arm (titrated dose)
clozapine (titrated dose)
Feinstein Institute for Medical Research
Glen Oaks, New York, United States
Total change in BPRS Symptoms
To compare the 12-week response rate of CLZ versus FL-APs (both risperidone and aripiprazole) utilizing the BPRS
Time frame: 12 weeks
Weight Gain
To compare weight gain associated with 12 weeks of treatment with CLZ vs. FL-APs in 3B+ FEP patients.
Time frame: 12 weeks
Agranulocytosis
To compare rates of agranulocytosis in 3B+ FEP patients treated for 12 weeks with CLZ vs. 3B+ FEP patients treated with FL-APs
Time frame: 12 weeks
Neutropenia
To compare rates of neutropenia in 3B+ FEP patients treated for 12 weeks with CLZ vs. 3B+ FEP patients treated with FL-APs
Time frame: 12 weeks
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