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    Summary
    EudraCT Number:2022-001244-15
    Sponsor's Protocol Code Number:D22-P006
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-10-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2022-001244-15
    A.3Full title of the trial
    Efficiency of a composite personalised care on functional outcome in early psychosis:
    A Prospective Randomised Controlled Trial - PsyCARE_Trial
    Efficacité d'une prise en charge personnalisée composite sur les résultats fonctionnels dans la psychose précoce : un essai contrôlé randomisé prospectif.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficiency of a composite personalised care on functional outcome in early psychosis
    Efficacité d'une prise en charge personnalisée composite sur les résultats fonctionnels dans la psychose précoce
    A.3.2Name or abbreviated title of the trial where available
    PSYCARE
    A.4.1Sponsor's protocol code numberD22-P006
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGHU Paris Psychiatrie et Neurosciences
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportANR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGHU PARIS PSYCHIATRY ET NEUROSCIENCES
    B.5.2Functional name of contact pointLaura Nailler
    B.5.3 Address:
    B.5.3.1Street Address1 rue Cabanis
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.6E-mailinfo-recherche@ghu-paris.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VITAMINE B12 GERDA 250 micrograms divisible tablet
    D.2.1.1.2Name of the Marketing Authorisation holderSUBSTIPHARM
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCyanocobalamin
    D.3.9.3Other descriptive nameVITAMINE B12
    D.3.9.4EV Substance CodeSUB06837MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name FOLINORAL 25MG capsule
    D.2.1.1.2Name of the Marketing Authorisation holderTHERABEL LUCIEN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium folinate
    D.3.9.3Other descriptive nameFolinic Acid
    D.3.9.4EV Substance CodeSUB06052MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27.012
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg Adults, granules for oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderALPEX PHARMA (IRL) LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Granules for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcetylcysteine
    D.3.9.1CAS number 68-19-9
    D.3.9.4EV Substance CodeSUB05229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OMACOR, soft capsule
    D.2.1.1.2Name of the Marketing Authorisation holderBASF AS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEICOSAPENTANOIC ACID/DOCOSAHEXAENOIC ACID
    D.3.9.2Current sponsor codeOMEGA 3
    D.3.9.4EV Substance CodeSUB28845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number840
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    early psychosis
    E.1.1.1Medical condition in easily understood language
    early psychosis
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    (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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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);
    E.4Principal 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<70), and/or sensorimotor deficits incompatibles with cognitive training
    - Former treated episode of psychosis, schizophrenia spectrum disorder, schizoaffective, bipolar disorder or bipolar disorder
    - Current severe depression (i.e. MADRS > 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at V2 (3 to 4 month after the beginning of the treatment)
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open label randomised 2x2 factorial design (equivalent to a 4-arms clinical trial) ; 1:1:1:1 ratio
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    usual standard of care including a standardised psycho-education program
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be 1 year after Last visit Last Patient in order to complete all biological analyses
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months62
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    After their participation (i.e. after V3), the participants will be allowed to continue to use the e-health application for 3 months, including participants who were initially randomised to other arms of the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-28
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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