NCT07881016Toboroz
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 19.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 3000 (tervezett)
- Első benyújtás
- 2026. okt. 6.
- Kezdés
- 2026. jún. 11.
- Elsődleges befejezés
- 2031. jún.
- Fő szponzor
- Fondation FondaMental
- Betegségek
- Skizofrénia, Bipoláris zavar, Depresszió, Autizmus spektrumzavar
- NCT-szám
- NCT07881016
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 3000
- 2026. jún. 11. és az elsődleges befejezés (2031. jún.) között
- 16 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Unstabilised somatic or psychiatric condition
- Psychiatric disorder in the past 5 years (screened with the MINI interview)
- Unstabilised somatic condition
Egyéb
- Patients:
- 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:
- Contraindication to MRI
- Inability to give consent
- Pregnant or breastfeeding women
- Refusal to be informed of any abnormality detected on MRI
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 15 év – 60 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (16)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHU de Besançon | Besançon | Franciaország | Fut, nem toboroz |
| Centre Hospitalier Charles Perrens | Bordeaux | Franciaország | Toboroz |
| CHU de Brest | Brest | Franciaország | Toboroz |
| Centre Hospitalier Le Vinatier | Bron | Franciaország | Toboroz |
| CHU Clermont-Ferrand | Clermont-Ferrand | Franciaország | Fut, nem toboroz |
| Hopital Louis Mourier | Colombes | Franciaország | Toboroz |
| Hopital Albert Chenevier | Créteil | Franciaország | Toboroz |
| CHU Grenoble Alpes - Hôpital Nord | Grenoble | Franciaország | Toboroz |
| CHU de Lille | Lille | Franciaország | Fut, nem toboroz |
| Hopital Sainte-Marguerite | Marseille | Franciaország | Toboroz |
| CHU de Montpellier | Montpellier | Franciaország | Toboroz |
| GHU Sainte-Anne | Paris | Franciaország | Fut, nem toboroz |
| Hôpital Lariboisière | Paris | Franciaország | Toborzás még nem indult |
| Chu de Saint Etienne | Saint-Etienne | Franciaország | Toboroz |
| CHU de Toulouse | Toulouse | Franciaország | Fut, nem toboroz |
| CHU de Tours | Tours | Franciaország | Fut, nem toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.