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Personalized brain training and supplements aim to improve life for youth with psychosis

NCT ID NCT05796401

Disease control Sponsor: Centre Hospitalier St Anne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a personalized care plan for 500 young people aged 15-30 with early psychosis. The plan combines cognitive training (using apps and virtual reality) with supplements (vitamin B12, folinic acid, Omega 3, NAC) tailored to each person's needs. The goal is to improve daily functioning and social skills, not to cure the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin B12, folinic acid, Omega 3, NAC
What this could lead to
If successful, this could provide a personalized treatment plan that improves daily functioning and quality of life for young people with early psychosis.
What could go wrong
This is a Phase 3 trial, but the approach is complex and relies on multiple components. The supplements and cognitive training may not work for everyone, and results may take time to show.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psychotic disorder Psychotic Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psychosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • C.H. Guillaume Regnier

    RECRUITING

    Rennes, France

  • CH Orsay

    RECRUITING

    Orsay, France

  • CHRU Brest

    RECRUITING

    Brest, France

  • CHU Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Poitiers

    RECRUITING

    Poitiers, France

  • CHU Purpan

    NOT_YET_RECRUITING

    Toulouse, France

  • Centre Esquirol - CHU CAEN

    RECRUITING

    Caen, France

  • Centre Hospitalier La Chartreuse

    NOT_YET_RECRUITING

    Dijon, France

  • Eldorado - Maison des Adolescents de Meurthe et Moselle

    RECRUITING

    Nancy, France

  • GHU Paris Neurosciences Psychiatrie

    RECRUITING

    Paris, France

  • Hôpital Fontan

    RECRUITING

    Lille, France

  • Hôpital La Colombière - CHU Montpellier

    RECRUITING

    Montpellier, France

  • Nineteen GHU

    NOT_YET_RECRUITING

    Paris, France

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