Biomarkers to predict mood-related versus other courses and treatment response after a first psychotic episode
Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 217 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 6 sites (Angers and 5 other locations) |
| Trial ID | NCT05384392 on ClinicalTrials.gov |
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.
Who should consider this trial
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).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 5 other locations
- Dr Bénédicte GOHIER — Angers, France (Not_yet_recruiting)
- Dr Florian STEPHAN — Brest, France (Recruiting)
- Dr Anne SAUVAGET — Nantes, France (Not_yet_recruiting)
- Dr Sonia MARSELLA — Quimper, France (Not_yet_recruiting)
- Dr Dominique DRAPIER — Rennes, France (Not_yet_recruiting)
- Dr Vincent CAMUS — Tours, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Florian STEPHAN
- Email: florian.stephan@chu-brest.fr
- Phone: 2.98.34.77.34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.