NCT06453174Active, not recruiting
CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project
Source: ClinicalTrials.gov · Last updated 30 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 7 Jun 2024
- Start date
- Jan 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Diseases
- Schizophrenia
- NCT number
- NCT06453174
What you commit to
- Study type: Observational
- Planned participants: 300
- From Jan 2024 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to 35 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Investigacion Biomedica de Salamanca (IBSAL) Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.