Biomarkers to predict mood-related versus other courses and treatment response after a first psychotic episode
Official title: Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode
Run by University Hospital, Brest · NCT05384392 · Data updated 2026-11-12
This project will test whether recorded interviews, clinical scales, blood markers and brain imaging can help predict who will go on to develop mood-related psychosis (bipolar/depressive with psychotic features) versus other psychoses and who will respond to treatment over two years in people aged 15–30 after their first psychotic episode.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 30 Years |
| Sex | All |
| Enrollment | 217 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 5 sites (Angers and 4 other locations) |
| Status | Recruiting |
| Started | March 27, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2030 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT05384392 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are French-speaking individuals aged 15–30 who are experiencing their first episode of psychosis and can provide informed consent (or have parental consent if minors).
✕Probably not a fit
People with psychosis due to an identified organic cause, substance-induced psychosis with severe dependence, significant intellectual disability, recent changes in antipsychotic/antidepressant/mood-stabilizing treatment, non–French speakers, pregnant or breastfeeding women, or those unable to consent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
People aged 15–30 experiencing a first psychotic episode are enrolled and complete recorded clinical interviews, standardized symptom scales, blood sampling for biological markers, and brain imaging where possible. Clinical status and treatment response are tracked over a two-year follow-up period. Collected data will be analyzed with statistical and predictive models to identify baseline biomarkers and interview features that distinguish mood-related (thymic) courses from other psychoses and that predict therapeutic response. The goal is to combine clinical, biological, and imaging signals to improve early diagnostic clarity and guide treatment choices.
Why it matters
Potential benefit: If successful, the approach could enable earlier, more accurate determination of psychosis type and more personalized initial treatment, which may reduce delays to appropriate therapy and lower relapse risk.
How similar studies have gone: Previous work has identified some candidate clinical, blood, and imaging markers in early psychosis, but predictive accuracy remains limited and combining recorded interviews with biomarkers for two-year outcome prediction is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Dr Efflam BREGEON
Angers, France Recruiting -
Dr Florian STEPHAN
Brest, France Recruiting -
Dr Dominique DRAPIER
Rennes, France Recruiting -
Dr Vincent CAMUS
Tours, France Recruiting -
Dr Anne SAUVAGET
Nantes, France Not yet recruiting
Study contacts
- Study coordinator: Florian STEPHAN
- Email: florian.stephan@chu-brest.fr
- Phone: 2.98.34.77.34
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.