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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

June 15, 2023

Primary Completion Date

July 15, 2026

Study Completion Date

June 15, 2028

Conditions
Psychosis
Interventions
BEHAVIORAL

Cognitive training

"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))"

DRUG

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

"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"

OTHER

Treatment as usual (TAU)

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)

Trial Locations (13)

Unknown

CHRU Brest, Brest

Centre Esquirol - CHU CAEN, Caen

CHU Clermont Ferrand, Clermont-Ferrand

Centre Hospitalier La Chartreuse, Dijon

Hôpital Fontan, Lille

Hôpital La Colombière - CHU Montpellier, Montpellier

Eldorado - Maison des Adolescents de Meurthe et Moselle, Nancy

CH Orsay, Orsay

GHU Paris Neurosciences Psychiatrie, Paris

Nineteen GHU, Paris

CHU Poitiers, Poitiers

C.H. Guillaume Regnier, Rennes

CHU Purpan, Toulouse

All Listed Sponsors
lead

Centre Hospitalier St Anne

OTHER

NCT05796401 - Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis | Biotech Hunter | Biotech Hunter