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Actively Recruiting

Phase 4
Age: 18Years - 35Years
All Genders
ID06969755

Early Treatment Study Using Biomarkers to Guide Clozapine, Risperidone, or Aripiprazole for First Episode Psychosis in Adults 18 to 35

Led by Northwell Health · Updated on 2026-07-31

180

Participants Needed

5

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating treatment options for adults aged 18 to 35 experiencing their first episode of psychosis who also have specific genetic markers that may influence their response to antipsychotic medications. The study aims to compare the effects of early treatment with clozapine against standard treatments with risperidone or aripiprazole in patients identified as biomarker positive for better response and lower risk of certain side effects. Participants will be screened using brain imaging rs-fMRI and genetic blood tests to identify three biomarkers related to treatment response, risk of weight gain, and risk of agranulocytosis. Those who meet all biomarker criteria will be randomly assigned to receive clozapine, risperidone, or aripiprazole, each given in titrated doses according to the study protocol. The treatments will be administered under careful monitoring during the study period. Throughout the study, participants will undergo assessments including symptom rating scales like the Brief Psychiatric Rating Scale BPRS, weight monitoring, blood tests for agranulocytosis and neutropenia, and brain scans as needed. These measurements will be taken over 12 weeks to evaluate changes in symptoms and side effects. The study involves regular visits and monitoring to ensure safety and adherence, with the total participation lasting up to 12 weeks after enrollment.

CONDITIONS

Brief Title

Biomarkers to Enhance Early Schizophrenia Treatment

Research Team

P

Patricia Marcy

C

Cristina Gonzalez

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