An interventional study of a mobile application for cognitive training and video games in First Episode Psychosis (FEP), sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Treatment
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Among 11 studies in Schizophrenia by Centre Hospitalier St Anne — 7 open to participants now, 7 under way, none of them phase 3. Schizophrenia · Centre Hospitalier St Anne.
Among the 11 studies in Schizophrenia by Centre Hospitalier St Anne, this one is the 3rd largest by planned enrollment, is the only one that started in 2021, is one of 11 with no phase, and was the 9th registered.
3,567 studies on the registry are indexed under Schizophrenia; 493 are open to participants now.
Browse Schizophrenia studies →7 of the 11 studies in Schizophrenia by Centre Hospitalier St Anne are open now, in 1 country. Recruiting first, the newest first:
Centre Hospitalier St Anne · Sites in France
Ages 18+
Centre Hospitalier St Anne · Sites in France
Ages 18–60
Centre Hospitalier St Anne · Sites in France
Ages 18+ · Healthy volunteers
Centre Hospitalier St Anne · Sites in France
Ages 15–30 · Healthy volunteers
Centre Hospitalier St Anne
Ages 18–30
By country, each count listing its studies:
Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 16 Years to 35 Years · all sexes · healthy volunteers too.
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11 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2021.
This study's planned enrollment of 240 is above the median of 71 across 2,947 interventional studies indexed under Schizophrenia.
Median enrollment 140 across the 11 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
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Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
2 of the studies in Schizophrenia by Centre Hospitalier St Anne that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06634446Centre Hospitalier St AnneSelf-administered COgnitive Personalized Training in Early Psychosis | 2026-12-30 |
| NCT06613334Centre Hospitalier St AnneVoice-Based Biomarkers: A Novel Approach to Monitoring and Predicting Schizophrenia Relapses | 2027-04 |
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Among the 11 studies in Schizophrenia by Centre Hospitalier St Anne, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities.
Cognitive remediation improves quality of life 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 FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions.
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.
Our background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the experimental group will use a mobile application for cognitive training for 3 months.
Device: a mobile application for cognitive training
Patients in the control group will use video games with no prominent cognitive involvement
Device: video games
Personalized cognitive training (PCT) HappyNeuronwill be delivered via a tablet or mobile application for 24 hours within 12 weeks, with a weekly supervision-call to reinforce their motivation. HappyNeuron Pro is a digital therapy tool designed for clinicians to provide engaging cognitive therapy via a web-based platform. It is compatible with PC, Mac, iPad, and Android devices and is available in multiple languages. The tool features exercises from established cognitive remediation programs. Functionality: The program offers 22 cognitive exercises targeting seven key functions outlined in the MATRICS framework: Processing Speed, Selective Attention, Reasoning and Working Memory, Verbal Memory, Visual Memory, and Auditory Memory. Exercises are customizable to meet individual patient needs, facilitating personalized cognitive training. User Experience: Each session comprises brief, self-administered exercises, with the order and difficulty adjusted by clinicians.
Also known as: cognitive training, HappyNeuron Pro, Personalized cognitive training
Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement
Primary assessment criterion
The main outcome will be the global functioning measured by the Personal and Social Performance (PSP) Scale after 3 months of cognitive training . The PSP is a 100-point single-item rating scale. The ratings are done by a clinician, in 5-10 min, and require minimal training, with excellent inter-rater reliability. The scale considers 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 (hereit will be the last month). It was found to be a quick and valid measure, sensitive to change, of patients; personal and social functioning even in early stage of psychosis.
Time frame: Month 9
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Dec 2026, 62 months after the start.
Of 756 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 62 months is above that.
Counting every sponsor, half of 769 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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