Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: 3T Brain MRI for Schizophrenia / Schizoaffective Disorder

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.

Official registry: https://clinicaltrials.gov/study/NCT07881016 · Fondation FondaMental · enrollment listed as 3,000

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 3T Brain MRI, Biological Sampling, or Clinical, Cognitive and Digital Assessments. The registry lists allocation as randomized. 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).

They plan to enroll about 3,000 people at 17 sites. Taking part typically means a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: 3T Brain MRI, Biological Sampling, Clinical, Cognitive and Digital Assessments

Primary outcome (registry wording): Proportion of participants in each transdiagnostic subgroup defined by social withdrawal and anhedonia.

Who it is for (from inclusion criteria)

  • Ages 15 Years to 60 Years
  • Aged 15 to 60 years at inclusion
  • Already assessed in a FondaMental expert centre or a First Episode Psychosis (PEP) / RHU PsyCare centre
  • Confirmed DSM-5 diagnosis at inclusion of at least one of the following:
  • Non-specific first-episode psychosis\*
  • Major depressive disorder (recurrent or treatment-resistant)
  • Autism spectrum disorder without intellectual disability
  • Clinical condition compatible with clinical, biological and imaging assessments

Public study contact (from the registry)

Imene Ben Mohamed

+33 7 58 25 17 49

imene.benmohamed@fondation-fondamental.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

17 listed

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FAQ about this NCT record

Is NCT07881016 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07881016?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07881016?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary