PsychosisPhase 3PSYCARENCT05796401
Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis
A Phase 3 study testing Cognitive training, Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC and Treatment as usual (TAU) in people with Psychosis, run by Centre Hospitalier St Anne at 13 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive training, Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 13 sitesFrance
- Study dates
- 15 Dec 2023to 15 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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),
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
CHRU Brest
Brest
Christophe LEMEY
Christophe LEMEY
- Recruiting
Centre Esquirol - CHU CAEN
Caen
Sonia DOLLFUS
Sonia DOLLFUS
- Recruiting
CHU Clermont Ferrand
Clermont-Ferrand
Isabelle JALENQUES
Isabelle JALENQUES
- Not yet recruiting
Centre Hospitalier La Chartreuse
Dijon
Juliette MARTIN
Juliette MARTIN
- Recruiting
Hôpital Fontan
Lille
Renaud JARDRI
Renaud JARDRI
- Recruiting
Hôpital La Colombière - CHU Montpellier
Montpellier
Diane PURPER OUAKIL
Diane PURPER OUAKIL
- Recruiting
Eldorado - Maison des Adolescents de Meurthe et Moselle
Nancy
Vincent LAPREVOTE
Vincent LAPREVOTE
- Recruiting
CH Orsay
Orsay
Julie BOURGIN
Julie BOURGIN
- Recruiting
GHU Paris Neurosciences Psychiatrie
Paris
Marie-Odile KREBS
Marie-Odile KREBS
- Not yet recruiting
Nineteen GHU
Paris
Gilles MARTINEZ
Gilles MARTINEZ
- Recruiting
CHU Poitiers
Poitiers
Nematollah JAAFARI
Nematollah JAAFARI
- Recruiting
C.H. Guillaume Regnier
Rennes
Dominique DRAPIER
Dominique DRAPIER
- Not yet recruiting
CHU Purpan
Toulouse
Grégoire BENVEGNU
Jean-Philippe RAYNAUD
About this study
Official title: PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "
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 anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy.
Read more
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.
- Conditions
- Psychosis
- Being tested
- Cognitive training, Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC, Treatment as usual (TAU)
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
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, NACDrug
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), 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)
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Not described Receives: Other: Treatment as usual (TAU) |
| TAU + cognitive training | Experimental | Not described Receives: Behavioral: Cognitive training; Other: Treatment as usual (TAU) |
| TAU + personalized neuroprotective strategies | Experimental | Not described Receives: Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC; Other: Treatment as usual (TAU) |
| TAU + personalized neuroprotective strategies + cognitive training | Experimental | Not described Receives: Behavioral: Cognitive training; Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC; Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global functioning
Global functioning will be assessed using the Personal and Social Performance Scale (PSP), a well-validated tool for the measurement of social functioning previously used in early psychosis.
PSP is a 100-point single-item rating scale (minimum value 1; maximum value: 100). The scale evaluates four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours during a determined reference period
Measured: 3 to 4 months after the beginning of intervention
Secondary outcomes (37)
Persistence of efficacy on global functioning
Score on the Personal and Social Performance Scale (PSP)
PSP is a 100-point single-item rating scale (minimum value 1; maximum value: 100). The scale evaluates four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours during a determined reference period
Measured: 6 to 8 months after the beginning of intervention
Persistence of efficacy on global functioning
Scores at Global Functioning Scale-Social and Role [120], measured at V2 and V3. This scale provides a 1 to 10 score separately for social role and for functioning.
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (1)
Comprehensive Assessment of At Risk Mental State (CAARMS) CAARMS evaluates seven dimensions of symptomatology. It provides operational criteria to categorise subjects as 'at-risk' or as psychotic (psychosis threshold) on the basis of the first subscale (10 min), 'positive symptoms' encompassing four sub-scales (Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities, Disorganised Speech)
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (2)
- SOFAS (Social and Occupational Functioning Assessment Scale or EFSP. SOFAS specifically estimates social functioning on a scale between 0 and 100.
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (3)
- MADRS (Montgomery-Asberg depression scale). MADRS is a 10 -item scale that evaluates different aspects of depressive symptomatology. It provides a good estimation of the severity of depression and is sensitive to change.
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (4)
- Brief Psychiatric Rating Scale (BPRS). BPRS is a scale that evaluates general psychiatric symptomatology.
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (5)
PANSS (Positive and Negative Syndrome Scale) PANSS is a 30-item scale widely used in schizophrenia research to assess positive and negative psychotic dimensions as well as general symptomatology
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (6)
Clinical Global Impression (CGI) scale. CGI estimates the current severity, of illness on a 7-point scale, as well as evolution and therapeutic index in reference to the clinicians past experiences of similar patients (3 items).
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (7)
Clinical Global Impression (CGI) scale. CGI estimates the current severity, of illness on a 7-point scale, as well as evolution and therapeutic index in reference to the clinicians past experiences of similar patients (3 items).
Measured: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care on linguistic and discourse markers
The recording of the interview will allow to extract reliable linguistic metrics that will be processed semi-automatically.
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on neurological soft signs (1)
Neurological Soft Signs rating scale (NSS) assesses five factors: motor coordination, motor integration, sensory integration, quality of lateralization and involuntary movements or posture; as well as extrapyramidal symptoms (Simpson Angus Scale) and lateralization (Edinburgh questionnaire).
Measured: at baseline and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on neurological soft signs (2)
Electronic Neurological Soft Signs (eNNS) This device incorporates a new, tablet-based and clinically suitable app (behavioral tasks), including tasks designed to probe balance of excitation/inhibition (multi-finger tapping task), body scheme tasks where finger posture recognition is measured and visuomotor sequence learning under variable cognitive load (using visual attentional distractors).
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive complaints
Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) is a 21-item Likert-type scale that allows a quantitative approach of cognitive complaint.
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Verbal learning and memory)
Hopkins Verbal Learning Test
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Flexibility)
TMT A/B (Reitan, 1959)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Social cognition)
Consensus autour de la COgnition Sociale (CLACOS) (PerSo)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Selective attention)
D2-R test
Measured: 3 to 4 Month and 6 to 8 Month after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Verbal long-term memory)
Hopskins Verbal Learning Test (HVLT) delayed recall
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Visuospatial learning and memory)
Brief Visuospatial Memory test
Measured: 3 to 4 Month and 6 to 8 Month after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Planning abilities)
Shopping test (Martin 1972)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Speed processing)
Wechsler Adult Intelligence Scale (WAIS) (code)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Inhibition control)
Stroop (Incompatibility)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Visuospatial long-term memory)
Brief Visuospatial Memory test (BVMT) delayed recall
Measured: 3 to 4 Month and 6 to 8 Month after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Working Memory)
Wechsler Adult Intelligence Scale (WAIS) (Digit span)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on motivation
Behavioral inhibition system (BIS) and behavioral activation system (BAS)
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Embodiment ability in virtual reality environment
Embodiment ability in virtual reality environment will be assessed using a simulation of two districts of a lively city via the Vive Pro virtual reality kit
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Effect of Composite Personalised Care on Health-related quality-of-life (1)
Short Form -12 items quality of life questionnaire (SF-12) SF-12 is a multipurpose self-report measure of both physical and mental health status
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Effect of Composite Personalised Care on Health-related quality-of-life (2)
European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L)
EQ-5D-5L investigates 5 dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. These 5 dimensions are rated on 5 levels ranging from no problems to extreme problems.
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Effect of Composite Personalised Care on medication adherence
Medication adherence (MARS) is a short assessement (5 items) of the adherence to medication
Measured: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Acceptability of the program for the e-Health application
amount of time spent on the application
Measured: 3 to 4 months after the beginning of intervention
Patient's satisfaction with the e-health application
satisfaction score measured by the User Version of the Mobile Application Rating Scale (uMARS)
Measured: 3 to 4 months after the beginning of intervention
Level and changes of biological markers (metabolism of monocarbon compounds)
dosage of folates, B12 vitamin, homocysteine
Measured: at baseline and 6 to 8 months after the beginning of intervention
Level and changes of biological markers (lipid membranes)
lipid composition of the red blood cells membrane, including the major lipid classes, such as phosphatidylcholine (PC), phosphatidylserine (PS), sphingomyelin (SM), phosphatidylethanolamine (PE), PE plasmalogen and their molecular species)
Measured: at baseline and 6 to 8 months after the beginning of intervention
Longitudinal epigenetic and seric changes associated with outcome (1)
Levels of RNA (messenger RNA, microRNA, long non-coding RNA) will be assessed using next generation sequencing methods.
Measured: at baseline and 6 to 8 months after the beginning of intervention
Longitudinal epigenetic and seric changes associated with outcome (2)
Levels of RNA (messenger RNA, microRNA, long non-coding RNA) will be assessed using next generation sequencing methods.
Measured: at baseline and 6 to 8 months after the beginning of intervention
Cost-effectiveness of Composite Personalised Care
Incremental cost-effectiveness ratios (ICER) will assess the efficiency of CPC vs. TAU (overall and by component). They will be expressed in cost per quality-adjusted life-years (QALY) gained and in cost per PSP point gained.
Measured: at the end of the follow-up, up to 4 years
Budgetary impact analysis of the generalization of Composite Personalised Care
Total costs and health benefits associated with generalizing CPC will be assessed and compared to TAU over a 5-year period.
Measured: at the end of the follow-up, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start15 Dec 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Phase III, Prospective Randomised Open, Blinded End-point (PROBE) controlled trial stratified according to the developmental burden and centre, with 2x2 factorial designs (equivalent to a 4-arms clinical trial) in a 1:1:1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796401
- Sponsor's protocol ID
- D22-P006
- Acronym
- PSYCARE
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "
- ClinicalTrials.gov ID
- NCT05796401
- Acronym / sponsor ID
- PSYCARE / D22-P006
- Conditions
- Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Phase III, Prospective Randomised Open, Blinded End-point (PROBE) controlled trial stratified according to the developmental burden and centre, with 2x2 factorial designs (equivalent to a 4-arms clinical trial) in a 1:1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Other: Treatment as usual (TAU) |
| TAU + cognitive training | Experimental | Behavioral: Cognitive training, Other: Treatment as usual (TAU) |
| TAU + personalized neuroprotective strategies | Experimental | Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC, Other: Treatment as usual (TAU) |
| TAU + personalized neuroprotective strategies + cognitive training | Experimental | Behavioral: Cognitive training, Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC, Other: Treatment as usual (TAU) |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingCognitive 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)) | Behavioural | TAU + cognitive training, TAU + personalized neuroprotective strategies + cognitive training |
| Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NACPersonalised 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 | Drug | TAU + personalized neuroprotective strategies, TAU + personalized neuroprotective strategies + cognitive training |
| 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) | Other | TAU + cognitive training, TAU + personalized neuroprotective strategies, TAU + personalized neuroprotective strategies + cognitive training, Treatment as usual (TAU) |
Primary outcome
Global functioning
Time frame: 3 to 4 months after the beginning of intervention
Global functioning will be assessed using the Personal and Social Performance Scale (PSP), a well-validated tool for the measurement of social functioning previously used in early psychosis. PSP is a 100-point single-item rating scale (minimum value 1; maximum value: 100). The scale evaluates four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours during a determined reference period
37 secondary outcomes
Persistence of efficacy on global functioning
Time frame: 6 to 8 months after the beginning of intervention
Persistence of efficacy on global functioning
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (1)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (2)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (3)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (4)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (5)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (6)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care (CPC) on clinical outcome (7)
Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of Composite Personalised Care on linguistic and discourse markers
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on neurological soft signs (1)
Time frame: at baseline and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on neurological soft signs (2)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive complaints
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Verbal learning and memory)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Flexibility)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Social cognition)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Selective attention)
Time frame: 3 to 4 Month and 6 to 8 Month after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Verbal long-term memory)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Visuospatial learning and memory)
Time frame: 3 to 4 Month and 6 to 8 Month after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Planning abilities)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Speed processing)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Inhibition control)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Visuospatial long-term memory)
Time frame: 3 to 4 Month and 6 to 8 Month after the beginning of intervention
Efficiency of composite personalised care on cognitive functions (Working Memory)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Efficiency of composite personalised care on motivation
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Embodiment ability in virtual reality environment
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Effect of Composite Personalised Care on Health-related quality-of-life (1)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Effect of Composite Personalised Care on Health-related quality-of-life (2)
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Effect of Composite Personalised Care on medication adherence
Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention
Acceptability of the program for the e-Health application
Time frame: 3 to 4 months after the beginning of intervention
Patient's satisfaction with the e-health application
Time frame: 3 to 4 months after the beginning of intervention
Level and changes of biological markers (metabolism of monocarbon compounds)
Time frame: at baseline and 6 to 8 months after the beginning of intervention
Level and changes of biological markers (lipid membranes)
Time frame: at baseline and 6 to 8 months after the beginning of intervention
Longitudinal epigenetic and seric changes associated with outcome (1)
Time frame: at baseline and 6 to 8 months after the beginning of intervention
Longitudinal epigenetic and seric changes associated with outcome (2)
Time frame: at baseline and 6 to 8 months after the beginning of intervention
Cost-effectiveness of Composite Personalised Care
Time frame: at the end of the follow-up, up to 4 years
Budgetary impact analysis of the generalization of Composite Personalised Care
Time frame: at the end of the follow-up, up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive training, Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC and Treatment as usual (TAU) in people with Psychosis, run by Centre Hospitalier St Anne at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Odile KREBS (+33 1 45 65 74 97, marie-odile.krebs@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global functioning (time frame: 3 to 4 months after the beginning of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.