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

Centre Hospitalier St Anne

Status and phase: Not yet enrolling; Phase 3

Conditions: Psychosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05796401

D22-P006

Details and patient eligibility

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescent and young adults, both sexes, aged 15 to 30 years,
• From Community or academic clinics,
• Characterised as UHR or FEP according to the first four items of the Comprehensive Assessment of At Risk Mental State (CAARMS) (first subscale for psychosis) [8] during the last 12 months,
• Informed and written signed consent,
• Participant with regular health insurance

Exclusion criteria

• Severe and unstabilised medical conditions,
• Insufficient level in reading and/or French language,
• Current participation in another intervention trial,
• Enforced hospitalization ,
• Intellectual Deficiency (i.e. Intelligence Quotient<70), and / or sensorimotor deficits incompatible with the cognitive training,
• Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder,
• Current severe depression (i.e. 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 (higher than an average equivalent of daily number of 5 cannabis cigarettes). Current severe substance use disorder except for nicotine (SUD, Diagnostic and Statistical Manual of Mental Disorders version V (DSMV criteria) during the last 6 months and/or former severe SUD or dependence DSMIV during more than 5 years.
• Current cognitive remediation programme,
• Pregnant women, parturients, and lactating women,
• Individuals deprived of their liberty by a judicial or administrative decision,
• Individuals of legal age who are the subject of a legal protection measure or unable to express their consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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500 participants in 4 patient groups

Treatment as usual (TAU)

Active Comparator group

Treatment:

Other: Treatment as usual (TAU)

TAU + cognitive training

Experimental group

Treatment:

Other: Treatment as usual (TAU)

Behavioral: Cognitive training

TAU + personalized neuroprotective strategies

Experimental group

Treatment:

Other: Treatment as usual (TAU)

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

TAU + personalized neuroprotective strategies + cognitive training

Experimental group

Treatment:

Other: Treatment as usual (TAU)

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

Behavioral: Cognitive training