Testing personalised care with cognitive training in early psychosis
Tests personalised cognitive training and supplements in young people with early psychosis.
Plain-language title generated from the registry record
Registry title: Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis
Key facts
- Where
- Brest, Caen, Clermont-Ferrand, Dijon, Lille, Montpellier, Nancy, Orsay, Paris, Poitiers, Rennes, and Toulouse, FranceSee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 30 years old?
Source: NCT05796401, who can take part
Where in France
- CHRU BrestBrest, FranceTaking people
- Centre Esquirol - CHU CAENCaen, FranceTaking people
- CHU Clermont-FerrandClermont-Ferrand, FranceTaking people
- Centre Hospitalier La ChartreuseDijon, FranceNot yet recruiting
- Hôpital FontanLille, FranceTaking people
- Hôpital La Colombière - CHU MontpellierMontpellier, FranceTaking people
- Eldorado - Maison des Adolescents de Meurthe et MoselleNancy, FranceTaking people
- CH OrsayOrsay, FranceTaking people
- GHU Paris Neurosciences PsychiatrieParis, FranceTaking people
- Nineteen GHUParis, FranceNot yet recruiting
- CHU PoitiersPoitiers, FranceTaking people
- C.H. Guillaume RegnierRennes, FranceTaking people
- CHU PurpanToulouse, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier St Anne
- Trial code
- NCT05796401
- Record updated
- 20 April 2026
- Original description
Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery.Read full original descriptionShow less
PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "
Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery.
Pioneering epigenetic analyses indicate that psychosis onset involves oxidative stress and inflammation suggesting that neuroprotective strategies could limit or even prevent the onset of or the transition into a chronic disorder. Several biological factors associated with the emergence of psychosis can all be rectified by using safe and easily accepted supplements including alterations folate deficiency/hyperhomocysteinemia; redox imbalance and deficit in polyunsaturated fatty acids (PUFA). The prevalence of these anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy.
Cognitive remediation improves quality of life (QoL) and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in patients at ultra-high risk (UHR) for psychosis and patient with a first episode of psychosis (FEP) and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatising tools, such as applications with cognitive strategies, motivational tools and functioning guidance personalised according to the need of each individual. Patients can have access to it, wherever they live.
Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training.
The study hypothesis is that promoting neuroplasticity by cognitive training and personalised virtual psychoeducation guidance could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients UHR or FEP and that this effect is modulated by individual brain plasticity abilities. The overall objective of PsyCARE_trial is to improve early intervention in psychosis by providing a composite personalised care (CPC) that will enable personalised cognitive training and psychoeducation guidance, adapted to individuals' needs, cognitive abilities and biological background.
Inclusion: 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: Receiving therapeutic levels of antipsychotics for more than 12 months,; Current medication with benzodiazepine >30 mg per day equivalent diazepam; Severe and unstabilised medical conditions,; Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the inclusion criteria),; 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; 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; 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,; Current severe depression (in case of doubt, MADRS > 34),; Pregnant women, parturients, and lactating women,.