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RECRUITING
NCT07881016
NA

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

15 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2026-06-11

Completion Date

2031-06

Last Updated

2026-10-19

Healthy Volunteers

Yes

Interventions

PROCEDURE

3T Brain MRI

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.

PROCEDURE

Biological Sampling

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.

OTHER

Clinical, Cognitive and Digital Assessments

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).

Locations (17)

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