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Clinical Utility of Early Intervention Including the 5-Step Precision Medicine Method in First-Episode Psychosis:
Jesús Pérez1,2, David Heredero Jung2,3, Óscar Gonzalo1,2
1Universidad de Salamanca, Salamanca, Spain.
JMIR Research Protocols
|September 23, 2025
Summary
Personalized precision psychiatry using pharmacogenetics in early psychosis intervention improves antipsychotic adherence and outcomes. The CLUMP project offers a blueprint for implementing this approach in young patients.
Area of Science:
- Psychiatry and Mental Health
- Pharmacogenetics
- Precision Medicine
Background:
- Schizophrenia and other psychotic disorders pose significant challenges due to high disability and treatment costs.
- Antipsychotic discontinuation rates are high, necessitating personalized treatment strategies.
- Pharmacogenetics-guided personalized precision psychiatry offers a promising approach for first-episode psychosis.
Purpose of the Study:
- To evaluate if personalized precision psychiatry, incorporating pharmacogenetics via the 5-step precision medicine (5SPM) method, improves antipsychotic adherence and clinical outcomes in young patients with first-episode psychosis.
- To compare an early intervention model (PRINT program) using 5SPM against standard care.
Main Methods:
- A comparative study of two cohorts of patients with first-episode psychosis.
- Cohort 1 receives the PRINT program with 5SPM; Cohort 2 receives standard care.
- Primary outcome: 1-year all-cause discontinuation of antipsychotics. Secondary outcomes: pragmatic efficacy, tolerability, and functional outcomes.
Main Results:
- Ethics approval obtained June 2023; recruitment ongoing until May 2026.
- Data collection expected by June 2027, with analysis and project completion by December 2027.
- Comparative analysis includes environmental, clinical, and pharmacogenetic data from 300 patients.
Conclusions:
- The CLUMP project will establish a blueprint for implementing and assessing personalized precision psychiatry in early intervention for psychosis.
- This research aims to benefit young individuals experiencing their first episode of severe mental illness.
- The study will provide insights into improving treatment adherence and outcomes through pharmacogenetics.
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