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

NCT05796401 | Recruiting Phase 3

• 1 other identifier: D22-P006
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 13

Brief Summary

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

Psychosis

Outcome Measures

Primary Outcomes (1)

• Global functioning

  Global functioning will be assessed using the Personal and Social Performance Scale (PSP), a well-validated tool for the measurement of social functioning previously used in early psychosis. PSP is a 100-point single-item rating scale (minimum value 1; maximum value: 100). The scale evaluates four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours during a determined reference period

  3 to 4 months after the beginning of intervention

Secondary Outcomes (37)

• Persistence of efficacy on global functioning

  6 to 8 months after the beginning of intervention

• Persistence of efficacy on global functioning

  at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

• Efficiency of Composite Personalised Care (CPC) on clinical outcome (1)

  at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

• Efficiency of Composite Personalised Care (CPC) on clinical outcome (2)

  at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

• Efficiency of Composite Personalised Care (CPC) on clinical outcome (3)

  at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

Study Arms (4)

Treatment as usual (TAU)

ACTIVE COMPARATOR

Other: Treatment as usual (TAU)

TAU + cognitive training

EXPERIMENTAL

Behavioral: Cognitive training; Other: Treatment as usual (TAU)

TAU + personalized neuroprotective strategies

EXPERIMENTAL

Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC; Other: Treatment as usual (TAU)

TAU + personalized neuroprotective strategies + cognitive training

EXPERIMENTAL

Behavioral: Cognitive training; Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC; Other: Treatment as usual (TAU)

Interventions

Cognitive training BEHAVIORAL

Cognitive reinforcement using digital applications (PSYCARE application) during 12 weeks +/- virtual reality based cognitive remediation application : 24 sessions over 12 weeks (only for patients who have a higher cognitive deficits (TMTB score \>110s))

TAU + cognitive training; TAU + personalized neuroprotective strategies + cognitive training

Treatment as usual (TAU) OTHER

Treatment as usual (TAU), including a standardised psycho-education program with a group cognitive behavioural therapy (e.g. I\_Care - You Care) and, in FEP only, second generation antipsychotic from a restricted list (following the recommendations www.orygen.org.au)

TAU + cognitive training; TAU + personalized neuroprotective strategies; TAU + personalized neuroprotective strategies + cognitive training; Treatment as usual (TAU)

Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC DRUG

Personalised neuroprotective medication adapted to the individual's biological profile : * Vitamin B12 : 500 micrograms per day * Folinic acid : 50 mg per day * Omega 3 : 1380 mg EicosaPentaenoic Acid (EPA) + 1140 mg DocosaHexaenoic Acid (DHA) per day * N-acetyl-cysteine (NAC) : 2400 mg per day duration of supplementation(s) : 12 weeks

TAU + personalized neuroprotective strategies; TAU + personalized neuroprotective strategies + cognitive training

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (13)

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

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Training; Leucovorin; Docosahexaenoic Acids; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Marie-Odile KREBS

CONTACT

+33 1 45 65 74 97; marie-odile.krebs@inserm.fr

Khaoussou SYLLA

CONTACT

+331.45.65.73.35; K.SYLLA@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, Prospective Randomised Open, Blinded End-point (PROBE) controlled trial stratified according to the developmental burden and centre, with 2x2 factorial designs (equivalent to a 4-arms clinical trial) in a 1:1:1:1 ratio.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 3, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

FR (13)