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

RecruitingPhase 3Ages 15 Years - 30 YearsAllCentre Hospitalier St Anne
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In plain words

What the trial is, and whether it could suit you

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 anomal

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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, * Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the inclusion criteria), * 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
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What it tests

  • Cognitive training
  • Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC
  • Treatment as usual (TAU)
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Where

13 sites
CHRU Brest
Brest, France
Centre Esquirol - CHU CAEN
Caen, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Centre Hospitalier La Chartreuse
Dijon, France
Hôpital Fontan
Lille, France
Hôpital La Colombière - CHU Montpellier
Montpellier, France
Eldorado - Maison des Adolescents de Meurthe et Moselle
Nancy, France
CH Orsay
Orsay, France

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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