NCT05384392: PEPAMARKER

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

Recruiting now NA Last updated 8 September 2025

What this trial tests

NA trial testing Recorded interview in First-episode Psychosis in 217 participants. Currently enrolling.

Timeline

27 March 2025

Primary endpoint
1 March 2027

1 March 2030

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	217
Start date	27 March 2025
Primary completion	1 March 2027
Estimated completion	1 March 2030
Sites	6 locations across France

Drugs / interventions tested

• Recorded interview
• Clinical scales
• Blood sample — full drug profile →

Conditions studied

• First-episode Psychosis — all drugs for First-episode Psychosis →

Sponsor

University Hospital, Brest

Who can join

Adults 15 to 30, any sex, with First-episode Psychosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluation of thymic evolution
  Time frame: Day 0, Year 2
  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 w

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PEPAMARKER: a multicenter cohort study protocol on predictive biomarkers of affective <i>vs</i>. non-affective trajectories in first-episode psychosis.
   Terrisse R, Lemey C, Kim-Dufor DH, Miglianico L, et al · · 2025 · PMID 41614097 · DOI 10.3389/fpsyt.2025.1702187