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FRENCH-MINDSNCT07881016

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Proportion of participants in each transdiagnostic subgroup defined by social withdrawal and anhedonia.
Timeframe: Baseline (Visit 1)

Secondary (13)

Proportion of participants in each subgroup defined by cognitive flexibility, neurodevelopment, sensory processing, sleep and impulsivity
Prevalence of autoimmune psychosis, metabolic abnormalities and genetic abnormalities within identified subgroups
Hippocampal volume measured by 3T brain MRI in patients and healthy volunteers
Plasma high-sensitivity C-reactive protein concentration in patients and healthy volunteers
Polygenic risk score for schizophrenia in patients and healthy volunteers
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Number of multimodal participant clusters identified by unsupervised clustering of all collected data
Percentage of participants assigned to a different subgroup at 1-year follow-up compared with baseline
Long-term treatment response measured by the Alda scale total score
Global functioning measured by the Global Assessment of Functioning (GAF) score.
Percentage of patients with a psychiatric relapse during follow-up
Percentage of participants with a new medical comorbidity during follow-up
Household crowding index in successive residences over the lifetime.
Number of residential moves over the lifetime

Arms and interventions

PatientsOther

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.

Healthy VolunteersOther

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.

Procedures: 3T Brain MRI, Biological Sampling

Other: Clinical, Cognitive and Digital Assessments

Sites

17 sites in 1 country