A Phase 3 interventional study of Cognitive training and Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC in Psychosis, sponsored by Centre Hospitalier St Anne. Recruiting at 13 sites in France. Open to participants aged 15 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Centre Hospitalier St Anne · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 55 studies in Psychotic Disorders with a site in France — 30 open to participants now, 30 under way, 3 of them phase 3. Psychotic Disorders · France.
Among the 55 studies in Psychotic Disorders with a site in France, this one is the 5th largest by planned enrollment of the 40 interventional ones that give a count, is one of 10 that started in 2023, is one of 8 in phase 3, reaches primary completion later than 12 of the 29 other live ones, and was the 29th registered.
1,588 studies on the registry are indexed under Psychotic Disorders; 280 are open to participants now.
Browse Psychotic Disorders studies →30 of the 55 studies in Psychotic Disorders with a site in France are open now. Recruiting first, the newest first:
Fondation FondaMental · Sites in France
Ages 15–60 · Healthy volunteers
Centre Psychothérapique de Nancy · Sites in France
Ages 15–30
Centre Hospitalier Universitaire de Saint Etienne · Sites in France
Ages 18–55
University Hospital, Strasbourg, France · Sites in France
Ages 18+
MapLight Therapeutics · Sites in France, United States, Argentina and 12 more countries
Ages 55–90
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 204 Psychotic Disorders studies recruiting now, 53 (26%) set no upper age limit and 142 (70%) stop at 75 or younger; 50 take children under 18; 41 take healthy volunteers.
This study: 15 Years to 30 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
First in 1967; this study’s year is marked. 10 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 65 across 1,321 interventional studies indexed under Psychotic Disorders.
Median enrollment 123 across the 40 interventional studies, 48 across the 15 observational. Of the 19 that completed or were terminated, 4 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 55 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
Centre Hospitalier St Anne has 4 studies filed under Psychotic Disorders — fewer than ten, so there is no comparison to draw.
9 of the studies in Psychotic Disorders with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT05796401Phase 3Centre Hospitalier St AnneEfficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis | 2026-12-15 |
| NCT06464848Centre Hospitalier Universitaire de NīmesNarrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis | 2026-12 |
| NCT05550155University Hospital, CaenEfficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations | 2026-12-30 |
| NCT06649552Centre Psychothérapique de NancyFrench Validation of Schizophrenia Proneness Instrument- Child Youth | 2027-01-13 |
Add all 9 to your calendar (.ics) → With an account.
Among the 55 studies in Psychotic Disorders with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Treatment as usual (TAU)
Behavioral: Cognitive training · Other: Treatment as usual (TAU)
Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC · Other: Treatment as usual (TAU)
Behavioral: Cognitive training · Drug: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC · Other: Treatment as usual (TAU)
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))
Drug pages: Vitamin B 12 · Leucovorin · Omega-3 fatty acid · Acetylcysteine
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)
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
Time frame: 3 to 4 months after the beginning of intervention
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
Time frame: 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.
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)
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)
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)
\- SOFAS (Social and Occupational Functioning Assessment Scale or EFSP. SOFAS specifically estimates social functioning on a scale between 0 and 100.
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)
\- 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.
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)
\- Brief Psychiatric Rating Scale (BPRS). BPRS is a scale that evaluates general psychiatric symptomatology.
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)
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
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)
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).
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)
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).
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
The recording of the interview will allow to extract reliable linguistic metrics that will be processed semi-automatically.
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)
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).
Time frame: 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).
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
Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) is a 21-item Likert-type scale that allows a quantitative approach of cognitive complaint.
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)
Hopkins Verbal Learning Test
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)
TMT A/B (Reitan, 1959)
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)
Consensus autour de la COgnition Sociale (CLACOS) (PerSo)
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)
D2-R test
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)
Hopskins Verbal Learning Test (HVLT) delayed recall
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)
Brief Visuospatial Memory test
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)
Shopping test (Martin 1972)
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)
Wechsler Adult Intelligence Scale (WAIS) (code)
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)
Stroop (Incompatibility)
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)
Brief Visuospatial Memory test (BVMT) delayed recall
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)
Wechsler Adult Intelligence Scale (WAIS) (Digit span)
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
Behavioral inhibition system (BIS) and behavioral activation system (BAS)
Time frame: 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
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)
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
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)
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.
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
Medication adherence (MARS) is a short assessement (5 items) of the adherence to medication
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
amount of time spent on the application
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at the end of the follow-up, up to 4 years
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 months after the start.
Of 26 phase 3 interventional studies under Psychotic Disorders, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's planned 36 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Vitamin B 12 · Leucovorin · Omega-3 fatty acid · Acetylcysteine