NCT06453174

CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Instituto de Investigación Biomédica de Salamanca · Academic / Other
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: —

Summary

CLUMP is a project of translational research that intends to bridge the gap between what we already know about pharmacogenetics of antipsychotic drugs and what we still do to treat patients with first-episode psychosis (FEP). We aim to improve the adherence to antipsychotic drugs and, therefore, the outcomes of patients with FEP. To achieve this aim, our objectives are to: (1) Introduce a pioneering early intervention model of Personalised Precision Psychiatry, including pharmacogenetics, for patients with FEP; (2) ascertain whether such a model can reduce the elevated discontinuation rates of antipsychotic medications in this group; (3) assess the impact of this model on pragmatic efficacy and functional measures; (4) determine whether this innovation can bring cost benefit; and (5) establish a blueprint for implementing this precision model nationally and internationally. We shall compare all-cause discontinuation rates of the first prescribed antipsychotic medication (primary outcome), discontinuation rates by causes, pragmatic efficacy and tolerability measures, functional outcomes, and healthcare costs between two cohorts of patients with FEP followed for one year. One cohort will be comprised of patients treated before the implementation of the early intervention model of Personalised Precision Psychiatry, and the other of new patients treated under this model. Also, we shall compare pharmacogenetic information, and its implications for clinical management, between these patients and another national cohort of patients with either longer-term psychotic disorders or other mental health problems.

Conditions

• Psychosis

Interventions

Type	Name	Description
OTHER	Adherence to the first prescribed antipsychotic medication	We shall compare adherence to the first prescribed antipsychotic medication and pragmatic clinical and functional outcomes between two cohorts of patients with first-episode psychosis. One cohort will be comprised of patients treated before the implementation of an early intervention in psychosis model of Personalised Precision Psychiatry including pharmacogenetics, and the other of patients treated under this new model. Also, we shall compare the pharmacogenetic profiles and possible phenocopies (variations of phenotypes produced environmentally, e.g., due to polypharmacy, rather than genetically) between these first episode psychosis patients and a national cohort of patients with longer-term psychotic disorders or with other mental health conditions, to evaluate potential implications for clinical management at different stages of a psychotic illness, and across mental disorders.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-06-11
• Last updated: 2025-04-30

Locations

1 site across 1 country: Spain