Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis
NCT ID: NCT05796401
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2023-06-15
2028-06-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Treatment as usual (TAU)
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)
TAU + cognitive training
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))
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)
TAU + personalized neuroprotective strategies
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
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)
TAU + personalized neuroprotective strategies + cognitive training
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))
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
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)
Interventions
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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))
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
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
30 Years
ALL
No
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Locations
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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
GHU Paris Neurosciences Psychiatrie
Paris, , France
Nineteen GHU
Paris, , France
CHU Poitiers
Poitiers, , France
C.H. Guillaume Regnier
Rennes, , France
CHU Purpan
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Christophe LEMEY
Role: primary
Sonia DOLLFUS
Role: primary
Isabelle JALENQUES
Role: primary
Renaud JARDRI
Role: primary
Diane PURPER OUAKIL
Role: primary
Vincent LAPREVOTE
Role: primary
Julie BOURGIN
Role: primary
Marie-Odile KREBS
Role: primary
Gilles MARTINEZ
Role: primary
Nematollah JAAFARI
Role: primary
Jean-Philippe RAYNAUD
Role: primary
Other Identifiers
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D22-P006
Identifier Type: -
Identifier Source: org_study_id
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