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Recruiting NCT05384392

Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode

No phase Interventional First-episode Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recorded interview, Clinical scales, Blood sample.
Who it may be relevant to
Registry conditions: First-episode Psychosis. Basic parameters: 15 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Recorded interview
    A recorded clinical interview, transcribed verbatim and blinded analyzed
  • Other Clinical scales
    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)
  • Biological Blood sample
    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.

Primary outcome measures

  • Evaluation of thymic evolution [Time frame: Day 0, Year 2]
Secondary outcome measures (12)
  • Evaluation of thymic evolution according syntactic linguistic markers [Time frame: Day 0]
  • Evaluation of thymic evolution according semantic linguistic markers [Time frame: Day 0]
  • Inflammatory markers [Time frame: Day 0]
  • Evaluation of thymic evolution according PANSS [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according BPRS [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according CDSS [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according MADRS [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according Altman [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according YMRS [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according GAF [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according SF-36 [Time frame: Day 0, Year 1, Year 2]
  • Evaluation of thymic evolution according CGI [Time frame: Day 0, Year 1, Year 2]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 5 centers
  • Dr Efflam BREGEON — Angers
  • Dr Florian STEPHAN — Brest
  • Dr Anne SAUVAGET — Nantes
  • Dr Dominique DRAPIER — Rennes
  • Dr Vincent CAMUS — Tours

Publications

  • 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 41614097

Identifiers

NCT: NCT05384392 · 29BRC21.0196

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗