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French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls

Sponsor: Fondation FondaMental • ClinicalTrials.gov ID: NCT07881016

Registry updated: 2026-10-19

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Description

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.

Interventions

3T Brain MRI (Procedure)
Structural and functional 3T brain MRI (about 1 hour), performed at baseline (within 6 weeks of V1) and at 1-year follow-up (within 6 weeks of V3), using a protocol harmonised across sites by the CATI platform.
Biological Sampling (Procedure)
Fasting blood sample for research at V1 and V3 (genomics, transcriptomics, epigenetics, metabolomics, proteomics, immune and inflammatory markers, autoantibodies). Optional home stool collection at V1 and V3 for gut microbiome analysis.
Clinical, Cognitive and Digital Assessments (Other)
Standardised psychiatric interviews and rating scales, self-questionnaires, neuropsychological testing, physical and minor neurological examination at V1 and V3; digital phenotyping over one year using a study-provided smartphone (Kanopsy app) and a connected watch (activity, sleep, heart rate variability).

Eligibility criteria

Inclusion Criteria: 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 Exclusion Criteria: Patients: * Unstabilised somatic or psychiatric condition * 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: * Psychiatric disorder in the past 5 years (screened with the MINI interview) * Unstabilised somatic condition * Contraindication to MRI * Inability to give consent * Pregnant or breastfeeding women * Refusal to be informed of any abnormality detected on MRI

Conditions

Schizophrenia / Schizoaffective Disorder First Episode Psychosis (FEP) Bipolar Disorder (BD) Major Depressive Disorder (MDD Treatment-resistant Depression (TRD) Autism Spectrum Disorder (ASD

Locations

CHU de Besançon — Besançon, France
Centre Hospitalier Charles Perrens — Bordeaux, France
CHU de Brest — Brest, France
Centre Hospitalier Le Vinatier — Bron, France
CHU Clermont Ferrand — Clermont-Ferrand, France
CHU Clermont-Ferrand — Clermont-Ferrand, France
Hopital Louis Mourier — Colombes, France
Hopital Albert Chenevier — Créteil, France
CHU Grenoble Alpes - Hôpital Nord — Grenoble, France
CHU de Lille — Lille, France
Hopital Sainte-Marguerite — Marseille, France
CHU de Montpellier — Montpellier, France
GHU Sainte-Anne — Paris, France
Hopital Lariboisière — Paris, France
CHU de Saint-Étienne — Saint-Etienne, France
CHU de Toulouse — Toulouse, France
CHU de Tours — Tours, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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