Clinical trial NCT05384392: Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode
Official title: Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: First-episode Psychosis
Keywords: Bipolar Disorder
Schizophrenia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 217
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Evaluation of thymic evolution
timeFrame: Day 0, Year 2
Secondary outcomes:
measure: Evaluation of thymic evolution according syntactic linguistic markers
timeFrame: Day 0
measure: Evaluation of thymic evolution according semantic linguistic markers
timeFrame: Day 0
measure: Inflammatory markers
timeFrame: Day 0
measure: Evaluation of thymic evolution according PANSS
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according BPRS
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according CDSS
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according MADRS
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according Altman
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according YMRS
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according GAF
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according SF-36
timeFrame: Day 0, Year 1, Year 2
measure: Evaluation of thymic evolution according CGI
timeFrame: Day 0, Year 1, Year 2
Other outcomes:
Locations:
city: Angers
country: France
facility: Dr Bénédicte GOHIER
city: Brest
country: France
facility: Dr Florian STEPHAN
city: Nantes
country: France
facility: Dr Anne SAUVAGET
city: Quimper
country: France
facility: Dr Sonia MARSELLA
city: Rennes
country: France
facility: Dr Dominique DRAPIER
city: Tours
country: France
facility: Dr Vincent CAMUS
Study officials:
References: