NCT07881016Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Cohorte française Longitudinale et Multimodale de Patients Atteints de Troubles Majeurs de l'Humeur, de Troubles Psychotiques, de Troubles du Spectre de l'Autisme et de témoins
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and anhedonia (reduced ability to feel pleasure). The study includes adolescents and adults aged 15 to 60 with schizophrenia, a first psychotic episode, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, as well as healthy volunteers aged 18 to 60. The main questions it aims to answer are: * Can subgroups of patients sharing a common profile of social withdrawal and anhedonia be identified, with similar clinical, genetic, biological and brain imaging characteristics? * Do other dimensions (cognitive flexibility, neurodevelopmental, sensory and sleep disturbances, impulsivity) and specific clinical forms (e.g., autoimmune psychosis, metabolic abnormalities) define relevant subgroups, and how do these subgroups evolve over time? Researchers will compare patients with healthy volunteers to identify clinical and biological signatures specific to each subgroup. Participants will: * Attend an inclusion visit, two one-day assessment visits one year apart (clinical interviews, questionnaires, cognitive tests, fasting blood sample) and two brain MRI sessions * Optionally provide a stool sample collected at home * Complete questionnaires on a smartphone app and wear a connected watch (activity, sleep, heart rate) between visits * Take part in the study for about 18 months French Minds is conducted in about 35 centres in France and aims to include 2,500 patients and 500 healthy volunteers.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3000 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- 11 Jun 2026
- Primary completion date
- 30 Jun 2031
- Lead sponsor
- Fondation FondaMental
- Diseases
- Schizophrenia, Depression, Bipolar disorder, Autism
- NCT number
- NCT07881016
What you commit to
- Study type: Interventional
- Planned participants: 3000
- From 11 Jun 2026 to the primary completion date, 30 Jun 2031
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unstabilised somatic or psychiatric condition
- Psychiatric disorder in the past 5 years (screened with the MINI interview)
- Unstabilised somatic condition
Other
- Patients:
- Contraindication to MRI
- Emergency situation, inability to give consent, or under judicial protection (sauvegarde de justice)
- Pregnant or breastfeeding women
- Refusal to be informed of any abnormality detected on MRI
- Healthy volunteers:
- Contraindication to MRI
- Inability to give consent
- Pregnant or breastfeeding women
- Refusal to be informed of any abnormality detected on MRI
Who the study is looking for
- Patients:
- Aged 15 to 60 years at inclusion
- Already assessed in a FondaMental expert centre or a First Episode Psychosis (PEP) / RHU PsyCare centre
- Signed informed consent (and consent of parents/legal guardians for minors, or of the curator for adults under curatorship)
- Confirmed DSM-5 diagnosis at inclusion of at least one of the following:
- Non-specific first-episode psychosis\*
- Schizophrenia
- Bipolar disorder
- Major depressive disorder (recurrent or treatment-resistant)
- Autism spectrum disorder without intellectual disability
- Clinical condition compatible with clinical, biological and imaging assessments
- Affiliated with or beneficiary of a social security scheme
- Women of childbearing potential: negative blood or urine pregnancy test at inclusion
- Agrees to be informed of any abnormality detected on MRI \*Non-specific first-episode psychosis: patients aged 35 or younger, with significant functional impairment (SOFAS), presenting at least two concurrent psychotic symptoms (e.g., hallucinations, delusions, disorganisation) or a first onset of a psychotic disorder (ICD-10 F20-F29) or mood disorder with psychotic features (ICD-10 F30-F39), with the episode lasting more than 7 days and first frank psychotic symptoms having appeared less than 2 years ago.
- Healthy volunteers (matched to patients by sex and 10-year age group):
- Aged 18 to 60 years at inclusion
- Signed informed consent
- No personal or first-degree family history, in the past 5 years, of: non-specific first-episode psychosis, schizophrenia, bipolar disorder, recurrent or treatment-resistant depressive disorder, or autism spectrum disorder without intellectual disability
- No current prescription of antidepressant, antipsychotic, mood stabiliser or psychostimulant for a characterised disorder
- No use of antidepressant, antipsychotic, mood stabiliser or psychostimulant in the past 5 years
- Condition compatible with clinical, biological and imaging assessments
- Affiliated with or beneficiary of a social security scheme
- Women of childbearing potential: negative blood or urine pregnancy test at inclusion
- Agrees to be informed of any abnormality detected on MRI
Age in the registry: 15 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Active, not recruiting |
| Centre Hospitalier Charles Perrens Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier Le Vinatier Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Hopital Louis Mourier Coordinator of this site? Confirm its status | Colombes | France | Recruiting |
| Hopital Albert Chenevier Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| CHU Grenoble Alpes - Hôpital Nord Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Hopital Sainte-Marguerite Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| GHU Sainte-Anne Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
| CHU de Tours Coordinator of this site? Confirm its status | Tours | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.