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

Psychosis Clinical Trial

— CLUMP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06453174
• Other study ID #: PI23/00582
• Status: Active, not recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Instituto de Investigación Biomédica de Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria

• 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.
• For cohort two: This will not be a mandatory inclusion criterion, but all patients will be approached by our research team seeking their consent to obtain their pharmacogenetic profile for research purposes. Exclusion Criteria
• 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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto de Investigación Biomédica de Salamanca (IBSAL)	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Biomédica de Salamanca	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pragmatic efficacy, tolerability, and functional outcome measures	In both cohorts, we'll gather data on practical effectiveness, tolerability, and functional outcomes. This encompasses monitoring hospital admissions, ER visits, and outpatient clinic attendance during follow-up, as well as changes in medications, antipsychotic dose adjustments (using chlorpromazine dose equivalents), side effects (including BMI impact), and resumption of work or academic activities. Cohort one patients will additionally complete the EQ-5D-5L questionnaire to assess overall improvement and guide treatment decisions at month 6. They'll also undergo assessments using various scales including PANSS, Calgary Depression Rating Scale, BNSS, and UKU side effects rating scale.	30 months