Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode
PEPAMARKER
1 other identifier
interventional
217
1 country
6
Brief Summary
Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse. The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses. Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses. In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2022
CompletedFirst Posted
Study publicly available on registry
May 20, 2022
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
September 12, 2025
September 1, 2025
1.9 years
April 28, 2022
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of thymic evolution
The primary endpoint is the thymic evolution (yes or no) of the initial psychotic episode The prosodic linguistic markers (fundamental frequency and latency) will be measured at Day 0 during a routine clinical interview and wil enable to build a predictive model to predict the thymic evolution at 2 years in patients with a first psychotic episode. This is main objective of study. The assessment will be measured the answer yes or no, at 2 years, at question, is the psychotic episode a thymic disorder?".
Day 0, Year 2
Secondary Outcomes (12)
Evaluation of thymic evolution according syntactic linguistic markers
Day 0
Evaluation of thymic evolution according semantic linguistic markers
Day 0
Inflammatory markers
Day 0
Evaluation of thymic evolution according PANSS
Day 0, Year 1, Year 2
Evaluation of thymic evolution according BPRS
Day 0, Year 1, Year 2
- +7 more secondary outcomes
Study Arms (1)
Intervention
EXPERIMENTALAll patients included in the study will be required to complete the examinations specified in the protocol.
Interventions
A recorded clinical interview, transcribed verbatim and blinded analyzed
Answering to clinical scales : PANSS (Positive and Negative Syndrome Scale); BPRS (Brief Psychiatric Rating Scale); CDSS (Calgary Depression Scale for Schizophrenia); MADRS (Montgomery-Åsberg Depression Rating Scale); Altman; YMRS (Young Mania Rating Scale); GAF (Global Assessment of Functioning); SF-36 (36-Item Short Form Survey); CGI-S (Clinical Global Impression Scale) et CGI-I (CGI-Improvement)
Blood collection of inflammatory markers (IL-1, sIL-2R, IL-4, IL-6, IL-8 and TNF levels) and 2 EDTA tubes and 2 dry tubes for biological collection (plasma bank and serum bank). This blood sample will be taken during routine sampling.
Eligibility Criteria
You may qualify if:
- Patient with a first episode of psychosis,
- Aged between 15 and 30 years,
- Able to consent and having signed a consent form (parental consent for minors).
You may not qualify if:
- Introduction or increase of antipsychotic and/or antidepressant and/or thymoregulatory treatment in the last month,
- Mother tongue other than French,
- Psychotic episode due to an organic disorder,
- Psychotic episode induced by the use or withdrawal of toxic substances with severe dependence ,
- Intellectual deficit,
- Chronic inflammatory disease,
- Immunomodulatory treatment,
- Contraindication to MRI,
- Pregnant or breastfeeding woman,
- Patient under court protection, guardianship, curatorship or deprived of liberty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Dr Bénédicte GOHIER
Angers, 49033, France
Dr Florian STEPHAN
Brest, 29609, France
Dr Anne SAUVAGET
Nantes, 44093, France
Dr Sonia MARSELLA
Quimper, 29017, France
Dr Dominique DRAPIER
Rennes, 35703, France
Dr Vincent CAMUS
Tours, 37044, France
Related Publications (1)
Terrisse R, Lemey C, Kim-Dufor DH, Miglianico L, Stephan F. PEPAMARKER: a multicenter cohort study protocol on predictive biomarkers of affective vs. non-affective trajectories in first-episode psychosis. Front Psychiatry. 2026 Jan 14;16:1702187. doi: 10.3389/fpsyt.2025.1702187. eCollection 2025.
PMID: 41614097DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2022
First Posted
May 20, 2022
Study Start
March 27, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2030
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
- Access Criteria
- Data access requests will be reviewed by the internal committee of BrestUH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication