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PsyCARE Trial - Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral, Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 30
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHRU Brest
RECRUITING
Brest
Centre Esquirol - CHU CAEN
RECRUITING
Caen
CHU Clermont Ferrand
RECRUITING
Clermont-ferrand
Centre Hospitalier La Chartreuse
NOT_YET_RECRUITING
Dijon
Hôpital Fontan
RECRUITING
Lille
Hôpital La Colombière - CHU Montpellier
RECRUITING
Montpellier
Eldorado - Maison des Adolescents de Meurthe et Moselle
RECRUITING
Nancy
CH Orsay
RECRUITING
Orsay
GHU Paris Neurosciences Psychiatrie
RECRUITING
Paris
Nineteen GHU
NOT_YET_RECRUITING
Paris
CHU Poitiers
RECRUITING
Poitiers
C.H. Guillaume Regnier
RECRUITING
Rennes
CHU Purpan
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Marie-Odile KREBS
marie-odile.krebs@inserm.fr
+33 1 45 65 74 97
Backup
Khaoussou SYLLA
K.SYLLA@ghu-paris.fr
+331.45.65.73.35
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2029-02-15
Participants
Target number of participants: 500
Treatments
Active_comparator: Treatment as usual (TAU)
Experimental: TAU + cognitive training
Experimental: TAU + personalized neuroprotective strategies
Experimental: TAU + personalized neuroprotective strategies + cognitive training
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier St Anne

This content was sourced from clinicaltrials.gov