An interventional study of 3T Brain MRI and Biological Sampling in Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP) and Bipolar Disorder (BD), sponsored by Fondation FondaMental. Recruiting at 17 sites in France. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Fondation FondaMental · Not applicable, Interventional, and Basic science
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:
Participants will:
Background and rationale Severe psychiatric disorders such as major mood disorders, psychotic disorders and autism spectrum disorders are clinically, genetically and biologically heterogeneous, which limits the efficacy of current treatments. Precision psychiatry requires deep and objective phenotyping of large samples to identify homogeneous subgroups that share common clinical and biological features and may benefit from targeted prevention and treatment strategies. Based on the literature and international consensus, social withdrawal and anhedonia are two particularly robust transdiagnostic dimensions with an underlying biological hypothesis, validated French measurement tools, existing translational models, and recognised relevance for patients.
French Minds is part of the French national research programme PEPR PROPSY (Precision Psychiatry), funded by the French government under France 2030. It extends pre-existing French psychiatric cohorts to build a multimodal database of more than 10,000 deeply phenotyped patients.
Study design National, multicentre, prospective, longitudinal cohort study (French "Jardé" law, category 1 interventional research not involving a health product). Patients are recruited in French Minds centres, i.e., the FondaMental Foundation expert centres and the First Episode Psychosis (PEP) / RHU PsyCare centres. Healthy volunteers are recruited through advertising and pre-screened by telephone, then assessed with the MINI interview at inclusion.
Study procedures
Biological samples are stored in a dedicated biobank (Hôpitaux Universitaires Henri Mondor, AP-HP). Genomic analyses are performed at the CNRGH (CEA) and MRI acquisition harmonisation, centralisation and quality control are handled by the CATI national neuroimaging platform.
Statistical analysis Approximately 500 patients per diagnostic group (2,500 patients) and 500 healthy volunteers will be included, allowing estimation of subgroup proportions (expected 20-50% per disorder) with 5% precision (alpha 5%), accounting for 20% loss to follow-up or refusal. Analyses will combine clustering methods, multivariate regression, analysis of variance, growth and survival models for longitudinal data, and exploratory data-mining / machine-learning approaches. Missing data will be handled by multiple imputation and multiple testing will be controlled using the false discovery rate (FDR).
Expected benefits There is no direct individual benefit; the expected benefit is collective, through improved understanding of prognostic factors and biological mechanisms in severe psychiatric disorders, with the potential to support the development of new, more personalised therapeutic strategies.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Fondation FondaMental is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Patients:
Healthy volunteers (matched to patients by sex and 10-year age group):
Exclusion Criteria:
Patients:
Healthy volunteers:
Patients aged 15 to 60 with schizophrenia, first-episode psychosis, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, followed in a French Minds centre (FondaMental expert centres or PEP / RHU PsyCare centres). Deep phenotyping at baseline and 1-year follow-up. Planned enrollment: 2,500.
Procedure: 3T Brain MRI · Procedure: Biological Sampling · Other: Clinical, Cognitive and Digital Assessments
Healthy volunteers aged 18 to 60 with no personal or first-degree family history of the studied psychiatric disorders and no psychotropic treatment in the past 5 years. Same deep phenotyping procedures as patients at baseline and 1-year follow-up. Planned enrollment: 500.
Procedure: 3T Brain MRI · Procedure: Biological Sampling · Other: Clinical, Cognitive and Digital Assessments
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.
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.
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).
Proportion of participants in each transdiagnostic subgroup defined by social withdrawal and anhedonia.
Participants are classified into mutually exclusive subgroups by unsupervised clustering of standardised scores from: Snaith-Hamilton Pleasure Scale (SHAPS; 0-14, higher = greater anhedonia); Self-evaluation of Negative Symptoms social withdrawal subscale (SNS; 0-8, higher = greater social withdrawal); UCLA Loneliness Scale v3 (20-80, higher = greater loneliness); Behavioral Activation System scales of the BIS/BAS questionnaire (13-52, higher = greater approach motivation); and percentage of optimal choices in the Reward Probabilistic Learning Task (0-100%, higher = better reward learning). The outcome is the percentage of participants assigned to each subgroup. Subgroups are then characterised by clinical, genetic, blood biomarker and brain MRI data (secondary outcomes).
Time frame: Baseline (Visit 1)
Proportion of participants in each subgroup defined by cognitive flexibility, neurodevelopment, sensory processing, sleep and impulsivity
Participants are classified into mutually exclusive subgroups by unsupervised clustering of standardised scores from: CANTAB Intra-Extra Dimensional Set Shift adjusted total errors (cognitive flexibility; higher = worse); neurological soft signs total score (higher = more signs); sensory processing questionnaire total score (higher = more sensory abnormalities); Insomnia Severity Index (0-28, higher = more severe insomnia); Hypersomnia Severity Index (0-36, higher = more severe hypersomnolence); Epworth Sleepiness Scale (0-24, higher = more daytime sleepiness); and Barratt Impulsiveness Scale version 11 (30-120, higher = more impulsivity). The outcome is the percentage of participants assigned to each subgroup.
Time frame: Baseline (Visit 1)
Prevalence of autoimmune psychosis, metabolic abnormalities and genetic abnormalities within identified subgroups
Proportion of participants with: autoimmune psychosis (clinical criteria such as abrupt onset, minor neurological signs, catatonia, treatment resistance, and presence of anti-neuronal autoantibodies); metabolic abnormalities (type 2 diabetes, obesity, metabolic syndrome, lipid disorders, mitochondrial and inflammatory abnormalities, assessed by anthropometric measures and blood tests); and genetic abnormalities (genetic sequencing).
Time frame: Baseline (Visit 1)
Hippocampal volume measured by 3T brain MRI in patients and healthy volunteers
Hippocampal volume (mm3) measured by structural 3T MRI, reported for healthy volunteers, all patients, and patients by diagnostic category.
Time frame: Visit 2, within 6 weeks of Visit 1
Plasma high-sensitivity C-reactive protein concentration in patients and healthy volunteers
Fasting plasma high-sensitivity C-reactive protein concentration (mg/L), reported for healthy volunteers, all patients, and patients by diagnostic category.
Time frame: Baseline (Visit 1)
Polygenic risk score for schizophrenia in patients and healthy volunteers
Polygenic risk score for schizophrenia (standardised units, z-score) computed from genome-wide genotyping data, reported for healthy volunteers, all patients, and patients by diagnostic category. Higher scores indicate greater genetic liability.
Time frame: Baseline (Visit 1)
Number of multimodal participant clusters identified by unsupervised clustering of all collected data
Unsupervised clustering after dimensionality reduction (e.g., principal component analysis) applied to all collected variables (clinical scales, cognitive tests, digital data, environmental data, omics and brain MRI). The optimal number of clusters is selected using internal validation indices (e.g., silhouette coefficient). The outcome is the number of distinct clusters identified.
Time frame: From baseline (Visit 1)
Percentage of participants assigned to a different subgroup at 1-year follow-up compared with baseline
The subgroup classification used for the primary outcome (clustering of social withdrawal and anhedonia scores) is repeated at 1-year follow-up. The outcome is the percentage of participants assigned to a different subgroup at Visit 3 than at Visit 1.
Time frame: From baseline (Visit 1) to 1-year follow-up (Visit 3, 12 to 14 months after Visit 1)
Long-term treatment response measured by the Alda scale total score
Clinician-rated Retrospective Criteria of Long-Term Treatment Response (Alda scale). Total score ranges from 0 to 10; higher scores indicate better treatment response.
Time frame: 1-year follow-up (Visit 3)
Global functioning measured by the Global Assessment of Functioning (GAF) score.
Clinician-rated Global Assessment of Functioning scale. Score ranges from 1 to 100; higher scores indicate better psychological, social and occupational functioning.
Time frame: Baseline (Visit 1) and 1-year follow-up (Visit 3)
Percentage of patients with a psychiatric relapse during follow-up
Relapse defined as the occurrence of at least one mood episode, psychotic episode or psychiatric hospitalisation between Visit 1 and Visit 3, assessed by clinical interview.
Time frame: From baseline (Visit 1) to 1-year follow-up (Visit 3)
Percentage of participants with a new medical comorbidity during follow-up
New-onset medical comorbidity (e.g., diabetes, hypertension, dyslipidaemia, obesity) between Visit 1 and Visit 3, assessed by medical questionnaire and routine blood tests.
Time frame: From baseline (Visit 1) to 1-year follow-up (Visit 3)
Household crowding index in successive residences over the lifetime.
Mean number of occupants per room across successive residences from the prenatal period to inclusion, collected by residential history questionnaire. Higher values indicate greater crowding.
Time frame: Baseline (Visit 1)
Number of residential moves over the lifetime
Number of changes of residence from the prenatal period to inclusion, collected by residential history questionnaire.
Time frame: Baseline (Visit 1)
Plan to share: Yes — Sharing data within the French Minds network and through scientific collaborations is a core value of the project. De-identified (pseudonymised) individual participant data collected in the cohort (clinical, cognitive, digital, environmental, omics and brain imaging data) will be shared with researchers through a governed access process. A data access charter describing access rules (submission file, evaluation of requests, provision of data) and publication policies (authorship, acknowledgements) is being finalised and will be made available online. Synthetic datasets will be made available in open access.
Supporting information: Study protocol, Informed consent form
Time frame: Participating French Minds centres and platform/dimension leads benefit from a 1-year priority period on their declared analysis plans (extendable upon approval by the Scientific Committee). Data will then be available to other researchers upon approved request, for the duration of the data warehouse.
Access criteria: Researchers must sign the data access charter, create a user account and submit an online data access request. Each request is reviewed by the French Minds Scientific Committee (scientific relevance, feasibility, data availability, computing resources, funding), which issues a reasoned opinion and decides on access. External requests from academic laboratories outside the FondaMental network require a Confidential Disclosure Agreement (CDA) and a Material Transfer Agreement (MTA); requests from private companies require a CDA and a partnership agreement. Approved data are accessed through a secure, certified health data hosting environment (HDS, SecNumCloud) in France, with individual access control and full traceability, in compliance with GDPR and CNIL requirements. Results are published under the supervision of the Scientific Committee and in association with the network coordinators.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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