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

NCT06453174 | Active Not Recruiting

• 1 other identifier: PI23/00582
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psychotic Disorders; Personalised Precision Psychiatry; Pharmacogenetics; First-episode psychosis

Outcome Measures

Primary Outcomes (1)

• All-cause discontinuation

  The CLUMP Project will gauge treatment adherence by tracking the cessation of initially prescribed antipsychotic medication, determined by either patients or treating clinicians. Discontinuation rates over a one-year follow-up period and the average time until discontinuation will be examined. For cohort one, follow-up begins when antipsychotic medication is prescribed based on pharmacogenetic guidance from the 5SPM method, while for cohort two, it starts at the time of the first antipsychotic prescription. Discontinuation is defined as the first day of a minimum 2-week interruption of the initially prescribed antipsychotic. Discontinuation dates will be extracted from clinical records, with approximations utilized if necessary.

  30 months

Secondary Outcomes (1)

• Pragmatic efficacy, tolerability, and functional outcome measures

  30 months

Study Arms (3)

Cohort one

A prospective sample of patients with a first episode psychosis referred over 18 months to the new early intervention in psychosis programme of Personalised Precision Psychiatry called PRINT - PRevention and early INTervention in mental health - at Salamanca University Healthcare Complex (CAUSA) in Salamanca, Spain.

Other: Adherence to the first prescribed antipsychotic medication

Cohort two

A retrospective, consecutive (in reverse chronological order as registered in CAUSA electronic health records) sample of patients who suffered a first-episode psychosis before the implementation of PRINT.

Other: Adherence to the first prescribed antipsychotic medication

Cohort three

For additional comparative purposes, we shall analyse environmental, clinical and pharmacogenetic information of patients with psychotic disorders of more than five years of evolution or with other mental disorders, whose data are currently stored, and ethically approved for research use, in our Unit of Pharmacogenetics and Precision Medicine at CAUSA.

Interventions

Adherence to the first prescribed antipsychotic medication OTHER

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.

Cohort one; Cohort two

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cohort one: A prospective sample of patients with a first episode psychosis referred over 18 months to the new early intervention in psychosis programme of Personalised Precision Psychiatry called PRINT - PRevention and early INTervention in mental health - at Salamanca University Healthcare Complex (CAUSA) in Salamanca, Spain. Cohort two: A retrospective, consecutive (in reverse chronological order as registered in CAUSA electronic health records) sample of patients who suffered a first-episode psychosis before the implementation of PRINT. Cohort three: For additional comparative purposes, we shall analyse environmental, clinical and pharmacogenetic information of patients with psychotic disorders of more than five years of evolution or with other mental disorders, whose data are currently stored, and ethically approved for research use, in our Unit of Pharmacogenetics and Precision Medicine at CAUSA.

You may qualify if:

• Patients with a diagnosis of first-episode psychosis, either non-affective or affective.
• Patients aged 12-35 years.
• Patients followed by clinical services for at least one year, or earlier if there was evidence of antipsychotic treatment discontinuation.
• For cohort one: Patients and/or their family or legal representatives must provide written consent to take part in the CLUMP Project, including pharmacogenetics analysis.

You may not qualify if:

• Patients with first-episode psychosis due to organic causes, for example, brain diseases such as Huntington's and Parkinson's disease, HIV, syphilis, dementia, brain tumours or cysts, or brain injury.
• Patients with moderate to severe intellectual disability.
• Patients who plan to reside (cohort one) or spent (cohort two) most of the one-year follow-up period in a locality outside of the PRINT's catchment area.

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Instituto de Investigación Biomédica de Salamanca (IBSAL)

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jesús Pérez Sánchez-Toledo, PhD MD

  Instituto de Investigación Biomédica de Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

ES (1)