RecruitingNot ApplicableNCT05384392

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


Sponsor

University Hospital, Brest

Enrollment

217 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 YearsMax Age: 30 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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.

Interventions

OTHERRecorded interview

A recorded clinical interview, transcribed verbatim and blinded analyzed

OTHERClinical 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)

BIOLOGICALBlood 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.


Locations(6)

Dr Bénédicte GOHIER

Angers, France

Dr Florian STEPHAN

Brest, France

Dr Anne SAUVAGET

Nantes, France

Dr Sonia MARSELLA

Quimper, France

Dr Dominique DRAPIER

Rennes, France

Dr Vincent CAMUS

Tours, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05384392


Related Trials