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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorUniversity Hospital, Brest

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 ,

Trial design

Design model

Single group

Treatments tested in this trial

  • Recorded interview

    Other intervention

    A recorded clinical interview, transcribed verbatim and blinded analyzed

  • Clinical scales

    Other intervention

    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 sample

    Biological/Vaccine

    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.

Treatment groups

217 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 3 interventions

Trial outcomes

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?".

Time frame
Day 0, Year 2

Secondary outcomes

1

Evaluation of thymic evolution according syntactic linguistic markers

The thymic evolution will be evaluated according syntactic linguistic markers at Day 0 during a clinical interview. Syntactic complexity is assessed using lexical density (%), lexical diversity (%), and the average number of words per clause. The use of the singular first-person pronoun "je" and speech disfluencies are also foregrounded in our project.

Time frame
Day 0
2

Evaluation of thymic evolution according semantic linguistic markers

The thymic evolution will be evaluated according semantic linguistic markers at Day 0 during a clinical interview. Semantic marker is grounded in a method for measuring semantic coherence called "latent semantic analysis (LSA)". LSA entails computing the cosine similarity between two vectors in each comparison of documents, i.e. between two sentences or between two turn-takings. Semantic coherence is consequently expressed by a value between -1 and 1.

Time frame
Day 0
3

Inflammatory markers

Assessment according inflammatory markers (IL-1, sIL-2R, IL-4, IL-6, IL-8 and TNF levels) at T0 during the initial biological work-up. The unit of measure is pg/mL for the inflammatory markers.

Time frame
Day 0
4

Evaluation of thymic evolution according PANSS

The thymic evolution will be evaluated according Positive and Negative Syndrome Scale (PANSS). The Positive and Negative Syndrome Scale (PANSS) is an established psychiatric rating system that is an operationalized, drug-sensitive instrument that offers balanced representation of positive and negative symptoms and estimates their relationship to one another and to global (or general) psychopathology. The scale has 30 items to explore and is scored from 1 (absence) to 7 (extreme).

Time frame
Day 0, Year 1, Year 2

Other outcomes

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