NCT05796401: PSYCARE

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

Not yet recruiting Phase 3 Last updated 27 April 2023

What this trial tests

Phase 3 trial testing Cognitive training in Psychosis in 500 participants. Not yet recruiting.

Timeline

15 June 2023

Primary endpoint
15 July 2026

15 June 2028

Quick facts

Lead sponsor	Centre Hospitalier St Anne
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	500
Start date	15 June 2023
Primary completion	15 July 2026
Estimated completion	15 June 2028
Sites	13 locations across France

Drugs / interventions tested

• Cognitive training
• Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC — full drug profile →
• Treatment as usual (TAU) — full drug profile →

Conditions studied

• Psychosis — all drugs for Psychosis →

Sponsor

Centre Hospitalier St Anne

Who can join

Adults 15 to 30, any sex, with Psychosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.