Actively Recruiting

Phase 3
Age: 15Years - 30Years
All Genders
NCT05796401

Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis

Led by Centre Hospitalier St Anne · Updated on 2026-04-20

500

Participants Needed

13

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis

Who Can Participate

Age: 15Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 15 to 30 years
  • Classified as ultra-high risk (UHR) or first episode of psychosis (FEP) within the first year after diagnosis and care
  • Provided informed written consent
  • Has regular health insurance
Not Eligible

You will not qualify if you...

  • Severe and unstable medical conditions
  • Insufficient reading or French language skills
  • Currently participating in another intervention trial or full cognitive remediation program
  • Enforced hospitalization
  • Intellectual deficiency (IQ below 70) or sensorimotor deficits incompatible with cognitive training
  • Previous treated psychosis episode, chronic schizophrenia, schizoaffective, or bipolar disorder prior to the last 12 months
  • Current severe depression (MADRS score above 34)
  • Taking antipsychotics at therapeutic levels for more than 12 months
  • Using benzodiazepines over 30 mg per day diazepam equivalent
  • Daily substance abuse other than nicotine or alcohol exceeding 5 cannabis cigarettes average or severe substance use disorder in last 6 months or over 5 years
  • Pregnant, breastfeeding, or parturient women
  • Legally deprived of liberty or under psychiatric care by legal order
  • Legal protection measures or unable to give consent

AI-Screening

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Trial Site Locations

Total: 13 locations

1

CHRU Brest

Brest, France

Actively Recruiting

2

Centre Esquirol - CHU CAEN

Caen, France

Actively Recruiting

3

CHU Clermont Ferrand

Clermont-Ferrand, France

Actively Recruiting

4

Centre Hospitalier La Chartreuse

Dijon, France

Not Yet Recruiting

5

Hôpital Fontan

Lille, France

Actively Recruiting

6

Hôpital La Colombière - CHU Montpellier

Montpellier, France

Actively Recruiting

7

Eldorado - Maison des Adolescents de Meurthe et Moselle

Nancy, France

Actively Recruiting

8

CH Orsay

Orsay, France

Actively Recruiting

9

GHU Paris Neurosciences Psychiatrie

Paris, France

Actively Recruiting

10

Nineteen GHU

Paris, France

Not Yet Recruiting

11

CHU Poitiers

Poitiers, France

Actively Recruiting

12

C.H. Guillaume Regnier

Rennes, France

Actively Recruiting

13

CHU Purpan

Toulouse, France

Not Yet Recruiting

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Research Team

M

Marie-Odile KREBS

CONTACT

K

Khaoussou SYLLA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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