Personalized neuroprotective supplements plus cognitive training for people with early or high‑risk psychosis

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

The trial offers systematic biological screening for common abnormalities (folate/homocysteine, redox markers, polyunsaturated fatty acids) and uses those results to guide personalized neuroprotective supplement strategies alongside cognitive training and standard care. Eligible participants are adolescents and young adults aged 15–30 who are either at ultra‑high risk (UHR) or within the first year after a first episode of psychosis (FEP). Interventions include targeted supplements (vitamin B12, folinic acid, omega‑3, N‑acetylcysteine), structured cognitive training, and treatment as usual. The approach tests whether early, personalized add‑on therapy during the window around first psychotic symptoms can improve functional recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adolescent and young adults, both sexes, aged 15 to 30 years,
* Persons characterised according to the CAARMS criteria \[8\] as UHR or FEP in the first year after having received diagnosis and care, if any
* Informed and written signed consent,
* Participant with regular health insurance

Exclusion Criteria:

* Severe and unstabilised medical conditions,
* Insufficient level in reading and/or French language,
* Current participation in another intervention trial or in a full cognitive remediation programme,
* Enforced hospitalization ,
* Intellectual Deficiency (i.e. Intelligence Quotient\<70), and / or sensorimotor deficits incompatible with the cognitive reinforcement,
* Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the inclusion criteria),
* Current severe depression (in case of doubt, MADRS \> 34),
* Receiving therapeutic levels of antipsychotics for more than 12 months,
* Current medication with benzodiazepine \>30 mg per day equivalent diazepam
* Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 5 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other than nicotine during the last 6 months or for more than 5 years.
* Pregnant women, parturients, and lactating women,
* Individuals deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L3212-1 and 3213-1 (Public Health Code),
* Individuals of legal age who are the subject of a legal protection measure or unable to express their consent

Where it's running

• CHRU Brest
  Brest, France Recruiting
• Centre Esquirol - CHU CAEN
  Caen, France Recruiting
• CHU Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• Hôpital Fontan
  Lille, France Recruiting
• Hôpital La Colombière - CHU Montpellier
  Montpellier, France Recruiting
• Eldorado - Maison des Adolescents de Meurthe et Moselle
  Nancy, France Recruiting

Study contacts

• Study coordinator: Marie-Odile KREBS
• Email: marie-odile.krebs@inserm.fr
• Phone: +33 1 45 65 74 97

Similar studies

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

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

• State Representation in Early Psychosis 2

  This observational study tests how people with early psychosis and healthy individuals use state information during tasks and how brain activity supports it.

  Recruiting at 2 sites University of Minnesota · Minneapolis, Minnesota and 1 other locations · NCT07834203

• Recovery-oriented suicide prevention for young people at clinical high risk for psychosis

  This program tests a peer-supported, clinician-led suicide prevention group for young people at clinical high risk for psychosis to see if it helps reduce suicidal thoughts and support recovery.

  Recruiting at 2 sites University of California, San Diego · Los Angeles, California and 1 other locations · NCT07756567

• Combined brain stimulation and yoga for improving cognition in psychosis

  This study tests whether active brain stimulation plus yoga can improve thinking skills and daily function in adults with psychosis.

  Recruiting The Hong Kong Polytechnic University · Hung Hom, Kowloon · NCT07747181

• See if an early-detection program reduces time to treatment for first-episode psychosis

  We test whether a large, region-wide early-detection program can shorten the time from first psychotic symptoms to treatment and help people function better later.

  Recruiting at 2 sites Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Copenhagen, Denmark and 1 other locations · NCT07716969

• Cerebellar imaging markers to predict antipsychotic response in first-episode psychosis

  This will test whether cerebellar brain scans can predict how people with first-episode psychosis respond to 12 weeks of treatment with risperidone or aripiprazole.

  Recruiting Phase 4 Northwell Health · Glen Oaks, New York · NCT07483294

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.