Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
500
Countries
1
Sites
14
Ultra High Risk of psychosis and first episode psychosis
To assess the efficacy of a composite personalised care (CPC) based on biological tests and clinical profile including (A) adaptation of add-on medications; (B) cognitive reinforcement using digital applications; or (A+B) their combination in patients with early psychosis, from baseline to 3 months, as compared as Trea…
Key facts
- Sponsor
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520573-39-00
- EudraCT number
- 2022-001244-15
- ClinicalTrials.gov
- NCT05796401
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To assess the efficacy of a composite personalised care (CPC) based on biological tests and clinical profile including (A) adaptation of add-on medications; (B) cognitive reinforcement using digital applications; or (A+B) their combination in patients with early psychosis, from baseline to 3 months, as compared as Treatment as usual (TAU) on global functioning measured by the Personal and Social Performance (PSP) Scale.
Secondary objectives 8
- Persistence of efficacy on PSP at V3.
- Efficiency of CPC on clinical outcome: psychopathological scales (PANSS, MADRS, CGI, rate of remission) and clinical record textual notes, prosodic and linguistic markers (audio recordings), neurological soft signs (NSS & eNSS), cognitive performance at V3.
- Effect of CPC on health-related QoL (SF-12 and EQ-5D-5L), medication adherence (MARS).
- 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)
- Longitudinal epigenetic and seric changes associated with outcome (seric and epigenetic markers).
- Cost-effectiveness of CPC (incremental cost-effectiveness ratio in cost per quality-adjusted life-years)
- Budgetary impact analysis (costs and health gains associated with the generalization of CPC)
- Acceptability and user’s satisfaction (number of effective sessions, satisfaction scores (uMARS)
Conditions and MedDRA coding
Ultra High Risk of psychosis and first episode psychosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Adolescent and young adults, both sexes, aged 15 to 30 years,
- - Persons characterised according to the CAARMS criteria as UHR or FEP in the first two years after having received diagnosis and care, if any
- - Informed and written signed consent
- - Participant with regular health insurance (AME is not considered as a regular health insurance)
Exclusion criteria 13
- 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 (ASPDT, ASPPI, ASPRE)
- Intellectual Deficiency (i.e. IQ<70), and / or sensorimotor deficits incompatible with a cognitive reinforcement
- Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 24 months established in the inclusion criteria)
- Current severe depression (in case of doubt, MADRS > 34 criterium)
- Receiving therapeutic levels of antipsychotics for more than 24 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 10 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other than nicotine during the last 12 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Global functioning will be assessed using the Personal and Social Performance Scale (PSP), determined reference period 3 to 4 months after the begning
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose
PRD7295333 · Product
- Active substance
- Acetylcysteine
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- BUCCAL USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- R05CB01 — ACETYLCYSTEINE
- Marketing authorisation
- 34009 278 263 3 7
- MA holder
- ALPEX PHARMA (IRL) LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Omacor 1000 mg capsules molles
PRD11860533 · Product
- Active substance
- OMEGA-3-ACID Ethyl Esters 90
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- BUCCAL USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- C10AX06 — OMEGA-3-TRIGLYCERIDES
- Marketing authorisation
- 2011071232
- MA holder
- BASF AS
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD1760601 · Product
- Active substance
- Calcium Folinate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- BUCCAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- 336 729-6
- MA holder
- THERABEL LUCIEN PHARMA S.A.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VITAMINE B12 GERDA 250 microgrammes, comprimé sécable
PRD9047321 · Product
- Active substance
- Cyanocobalamin
- Pharmaceutical form
- TABLET
- Route of administration
- BUCCAL USE
- Max daily dose
- 500 µg microgram(s)
- Max total dose
- 500 µg microgram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- B03BA01 — CYANOCOBALAMIN
- Marketing authorisation
- 34009 311 364 4 6
- MA holder
- SUBSTIPHARM
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Sponsor organisation
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Address
- 1 Rue Cabanis
- City
- Paris
- Postcode
- 75014
- Country
- France
Scientific contact point
- Organisation
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Contact name
- Khaoussou SYLLA
Public contact point
- Organisation
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Contact name
- Khaoussou SYLLA
Locations
1 EU/EEA country · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 500 | 14 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Psychotherapique De Nancy
UNité de recherche et d'Investigation Clinique (UNIC), 1 Rue Du Dr Archambault, 54521, Laxou
Centre Hospitalier Universitaire De Toulouse
PSYCHIATRIE, 2 Rue Viguerie, 31300, Toulouse
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
PSYCHIATRIE, 1 Rue Cabanis, 75014, Paris
Centre Hospitalier Universitaire De Lille
PSYCHIATRIE, Rue Andre Verhaeghe, 59000, Lille
Centre Hospitalier Universitaire Grenoble Alpes
PSYCHIATRIE, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Montpellier
Le CIPP Centre d'Intervention Précoce pour Psychose, 39 Avenue Charles Flahault, 34295, Montpellier Cedex 5
Centre Hospitalier Regional Et Universitaire De Brest
PSYCHIATRIE, 2 Avenue Marechal Foch, 29200, Brest
Centre Hospitalier La Chartreuse
PSYCHIATRIE, 1 Boulevard Chanoine Kir, 21000, Dijon
University Hospital Of Clermont-Ferrand
Unité Pass'âge Pôle Psychiatrie enfant-adulte, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospotalier Guillaume Regnier
PSYCHIATRIE, 108 Avenue General Leclerc, Bp 60321, Rennes
Groupe Hospitalier Nord Essonne
PSYCHIATRIE, ZAC De Corbeville, 1 Parvis De L Hopital, Orsay
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
PSYCHIATRIE, 1 Rue Cabanis, 75014, Paris
Centre Hospitalier Henri Laborit
PSYCHIATRIE, 370 Avenue Jacques Coeur, Cs 10587, Poitiers Cedex
Centre Hospitalier Universitaire De Caen Normandie
PSYCHIATRIE, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2025-520573-39-00 _PROTOCOLE_V5_20240730_PSYCARE_FINAL | 5 |
| Protocol (for publication) | D1_Protocol_2025-520573-39-00 | 6.0 |
| Recruitment arrangements (for publication) | 2025-520573-39-00 _Recruitment arrangements_PSYCARE - Signed | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF become adults | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF minors | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC folinoral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mucodrill | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Omacor | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vitamine B12 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_EN_2025-520573-39-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_FR_2025-520573-39-00 | 6.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-22 | France | Acceptable 2025-01-28
|
2025-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-23 | France | Acceptable 2026-04-27
|
2026-04-30 |