Personalized neuroprotective supplements plus cognitive training for people with early or high‑risk psychosis
PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "
PHASE3 · Centre Hospitalier St Anne · NCT05796401
This trial tests whether adding tailored supplements (B12/folinic acid, omega‑3, NAC) and cognitive training to usual care improves functioning in adolescents and young adults with recent or high‑risk psychosis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne (other) |
| Locations | 13 sites (Brest and 12 other locations) |
| Trial ID | NCT05796401 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adolescents and young adults aged 15–30 who meet CAARMS criteria for UHR or are within one year of a first episode of psychosis, can read French, provide informed consent, and have regular health insurance.
Not a fit: People with prior long‑treated chronic psychosis, intellectual disability (IQ <70), severe unstabilized medical conditions, current severe depression, ongoing enforced hospitalization, or who cannot read French are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve daily functioning and limit progression to chronic psychosis by correcting modifiable biological risks early on.
How similar studies have performed: Early intervention programs and trials of omega‑3 or NAC in prodromal/early psychosis have shown some promising but mixed results, and combining personalized supplementation with cognitive training is a relatively novel strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brest and 12 other locations
- CHRU Brest — Brest, France (RECRUITING)
- Centre Esquirol - CHU CAEN — Caen, France (RECRUITING)
- CHU Clermont Ferrand — Clermont-Ferrand, France (RECRUITING)
- Centre Hospitalier La Chartreuse — Dijon, France (NOT_YET_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)
- CH Orsay — Orsay, France (RECRUITING)
- GHU Paris Neurosciences Psychiatrie — Paris, France (RECRUITING)
- Nineteen GHU — Paris, France (NOT_YET_RECRUITING)
- CHU Poitiers — Poitiers, France (RECRUITING)
- C.H. Guillaume Regnier — Rennes, France (RECRUITING)
- CHU Purpan — Toulouse, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Marie-Odile KREBS
- Email: marie-odile.krebs@inserm.fr
- Phone: +33 1 45 65 74 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychosis