PsychosisCLUMPNCT06453174
CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project
An observational study of Psychosis, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Adherence to the first prescribed antipsychotic medication
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Investigación Biomédica de Salamanca (IBSAL)
Salamanca, 37007
About this study
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
- Being tested
- Adherence to the first prescribed antipsychotic medication
- Keywords
- Psychotic Disorders, Personalised Precision Psychiatry, Pharmacogenetics, First-episode psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to the first prescribed antipsychotic medicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (1)
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Jesús Pérez Sánchez-Toledo, PhD MD, Principal investigator, Instituto de Investigación Biomédica de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453174
- Sponsor's protocol ID
- PI23/00582
- Acronym
- CLUMP
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project
- ClinicalTrials.gov ID
- NCT06453174
- Acronym / sponsor ID
- CLUMP / PI23/00582
- Conditions
- Psychosis
- Keywords
- Psychotic Disorders, Personalised Precision Psychiatry, Pharmacogenetics, First-episode psychosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort one | – | Other: Adherence to the first prescribed antipsychotic medicationA 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 | – | Other: Adherence to the first prescribed antipsychotic medicationA 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. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence to the first prescribed antipsychotic medicationWe 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. | Other | Cohort one, Cohort two |
Primary outcome
All-cause discontinuation
Time frame: 30 months
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.
1 secondary outcome
Pragmatic efficacy, tolerability, and functional outcome measures
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Pérez Sánchez-Toledo, PhD MD principal investigator
Instituto de Investigación Biomédica de Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause discontinuation (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.