Actively Recruiting

Phase Not Applicable
Age: 15Years - 30Years
All Genders
NCT05384392

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

Led by University Hospital, Brest · Updated on 2025-09-12

217

Participants Needed

6

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 15Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Dr Bénédicte GOHIER

Angers, France, 49033

Not Yet Recruiting

2

Dr Florian STEPHAN

Brest, France, 29609

Actively Recruiting

3

Dr Anne SAUVAGET

Nantes, France, 44093

Not Yet Recruiting

4

Dr Sonia MARSELLA

Quimper, France, 29017

Not Yet Recruiting

5

Dr Dominique DRAPIER

Rennes, France, 35703

Not Yet Recruiting

6

Dr Vincent CAMUS

Tours, France, 37044

Not Yet Recruiting

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Research Team

F

Florian STEPHAN

CONTACT

C

Christophe LEMEY

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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