French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

French Minds is a national, multicenter, longitudinal cohort that deeply phenotypes individuals with schizophrenia, schizoaffective disorder, first-episode psychosis, bipolar disorder, major depressive disorder (including treatment-resistant cases), autism without intellectual disability, and healthy controls. Participants undergo 3T brain MRI, biological sampling, and comprehensive clinical, cognitive, and digital assessments to identify homogeneous subgroups with shared clinical and biological features. The study aims to map these subgroups to genetic, biological, and brain imaging patterns, and to explore additional dimensions such as cognitive flexibility, sleep, sensory processing, and metabolic factors that may define relevant clusters. The project is part of the PEPR PROPSY Precision Psychiatry program and seeks to build a large, multimodal database of more than 10,000 deeply phenotyped individuals across France.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier Charles Perrens
  Bordeaux, France Recruiting
• CHU de Brest
  Brest, France Recruiting
• Centre Hospitalier Le Vinatier
  Bron, France Recruiting
• CHU Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Hopital Louis Mourier
  Colombes, France Recruiting
• Hopital Albert Chenevier
  Créteil, France Recruiting

Study contacts

• Study coordinator: Imene Ben Mohamed
• Email: imene.benmohamed@fondation-fondamental.org
• Phone: +33 7 58 25 17 49

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Affective Cognitive Training for mood disorders and their close relatives

  A six-week program combining virtual reality and computer exercises tests whether affective cognitive training helps people with mood disorders and their unaffected first-degree relatives.

  Recruiting Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Frederiksberg, Capital Region of Denmark · NCT07920302

• Predicting Treatment Response in Psychiatric Disorders Using Biological Markers

  This study tests whether biological markers can predict which patients with psychiatric conditions will respond to treatment.

  Recruiting Centre Hospitalier St Anne · Paris · NCT07741981

• Cannabidiol Oil as an Add-on for Treatment-Resistant Major Depression

  This study tests whether full-spectrum CBD oil added to standard antidepressants can help adults with treatment-resistant major depression.

  Recruiting Phase 1/2 Universidade do Sul de Santa Catarina · Tubarão, Santa Catarina · NCT07696871

• Accelerated bilateral DMPFC iTBS for major depression

  This study tests whether a fast, multiple-daily session brain stimulation approach can help adults with major depressive disorder who have not fully benefited from standard antidepressants.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT07603804

• Ketamine with DBT for suicidality in adults with treatment-resistant depression or bipolar disorder and BPD

  This study tests whether four ketamine infusions plus Dialectical Behavioural Therapy can more quickly reduce suicidal thoughts in adults with Borderline Personality Disorder and treatment-resistant depression or bipolar disorder.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07569198

• Ketogenic Diet with Accelerated Brain Stimulation for Treatment‑Resistant Depression

  This study tests whether adding a ketogenic diet to a personalized accelerated brain stimulation treatment helps reduce depression symptoms in adults with treatment‑resistant depression.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07376018

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.