Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453174
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
CLinical Utility of Early Intervention Including the 5-Step Precision Medicine 5SPM Method in First-episode Psychosis The CLUMP Project
Sponsor:
Instituto de Investigación Biomédica de Salamanca
Organization:
Instituto de Investigación Biomédica de Salamanca
Study Overview
Official Title:
CLinical Utility of Early Intervention Including the 5-Step Precision Medicine 5SPM Method in First-episode Psychosis The CLUMP Project
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLUMP
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None