early psychosis
Conditions
Interventions
Trade Name: VITAMINE B12 GERDA 250 micrograms divisible tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyanocobalamin
Other descriptive name: VITAMINE B12
Concentration unit: µg microgram(s)
Sponsors
GHU Paris Psychiatrie et Neurosciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adolescent and young adults, both sex, aged 15 to 30 years, - from Community or academic clinics - Characterised as UHR or FEP according to the first four items of the CAARMS (first subscale for psychosis) [8] during the last 12 months. - Informed and written signed consent - Participant with regular health insurance (AME is not considered as a regular health insurance); Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Severe and unstabilised medical conditions - Insufficient level in reading and French language - Current participation in another intervention trial - Enforced hospitalization (ASPDT, ASPPI, ASPDRE, etc) - Intellectual Deficiency (IQ 34) - Receiving therapeutic levels of antipsychotics for more than 12 months (this is a common criterium for FEP programs in most international guidelines, as synthetized in the recent Canadian Guideline [152] - Current medication with benzodiazepine >30 mg per day diazepam equivalent - Current daily use of substance of abuse (higher than an average equivalent of daily number of 5 cannabis cigarettes) months current severe substance use disorder except for nicotine (SUD, 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, persons under psychiatric care (L3212-1 et 3223-1) - Individuals of legal age who are the subject of a legal protection measure or unable to express their consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess the effect of a composite personalised care (CPC), based on biological tests and clinical profile, including (A) adaptation of add-on neuroprotective medications, (B) digital cognitive reinforcement (A+B) or their combination, on functional outcome at three months in patients with early psychosis and patients at UHR for psychosis. All CPCs are associated to the standard of care ‘treatment as usual’ (TAU: psychoeducation and in FEP only antipsychotic) and compared to the control arm receiving treatment as usual (TAU) only.;Secondary Objective: (1) Persistence of efficacy on functional outcome at V3. (2) Efficiency of CPC on clinical and phenomenological outcomes (psychopathological scales, i.e. PANSS, MADRS, CGI, rate of remission, EASE), linguistic and discourse markers, neurological soft signs (NSS) and the new eNSS, cognitive complaints (STICCS) and functions, motivation and social cognition (‘Clacos’ tests) at V3. (3) Effect of CPC on health-related QoL (SF-12 and EQ-5D-5L), medication adherence (MARS 5 items) (4) Acceptability and user’s satisfaction (uMARS) (5) Influence on the outcome of biological background (biological tests) and of in vivo neuroimaging (VBM measures, sulcal patterns, regional and global functional connectivity, microstructural complexity of dendrites and axons) (6) Longitudinal epigenetic and seric changes associated with outcome (seric and epigenetic markers). (7) Cost-effectiveness of CPC (8) Budgetary impact analysis of the generalization of CPC.;Primary end point(s): The primary criterion will be global functioning, 3 months to 4 month after the beginning of the treatment (A) and treatment (B), assessed using the Personal and Social Performance Scale (PSP), a well-validated tool for the measurement of social functioning previously used in early psychosis. ;Timepoint(s) of evaluation of this end point: at V2 (3 to 4 month after the beginning of the treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Persistence of efficaiency on global functioning 6 months after CPC: (a) score at V3 after the end of cognitive training on the PSP (b) scores at Global Functioning Scale-Social and Role, measured at V2 and V3. (2) Efficiency of CPC on (a) clinical outcome (CAARMS, SOFAS, MADRS, Brief Psycatric Raing Scale, PANSS, CGI, EASE, STAI, CTQ, DTD, ADHD self Report Questionnaire, Autism Questionnaire, SNS) (b) linguistic and discourse markers (c) neurological soft signs (NSS, eNSS) (d) cognitive complaints (STCCS) and functions (CVLT, TMT A/B, CLACOS, D2R, CVLT, BVMT, shopping test, WAIS, Stroop, BVMT-R) (d) embodiement ability in virtual reality environment (HTC Vive Pro virtual reality kit) (e) Motivation (Behavioral inhibition system (BIS) and behavioral activation system (BAS)) (3) Health-related quality-of-life (SF-12, EQ-5D-5L, MARS) (4) For the e-health application, acceptability of the program and patient’s satisfaction (time spents on the application ; satisfaction score measured by the User Version of the Mobile Application Rating Scale (uMARS) (5) Influence of biological background on the outcome measures (biological testing an neuroimaging) (6) sociodemographic and clinical factors (7) Cost-effectiveness ( efficiency of CPC vs. TAU (overall and by component). (8) Budgetary impact analysis;Timepoint(s) of evaluation of this end point: (1) (a) at V3 (6 to 7 month after then end of the intervention) ; (b) at V2 (at the end of the intervention) (2) at V1 (before the intervention) , V2 (at the end of intervention) and V3 (6 to 8 month after then end of the intervention) (3) at V1, V2 and V3 (4) at V2 (5) at V1 and V3 (6) at V1, V2 and V3 (7) at V2 and V3 (8) at V2 and V3 | — |
Countries
France
Contacts
Public ContactLaura Nailler
GHU PARIS PSYCHIATRY ET NEUROSCIENCES
Outcome results
None listed