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NCT06818227: Mon Psy & Moi
MonPsy&Moi: A Digital Platform for Collecting Patient-Reported Experience and Outcome Measures in Psychiatry
trial in Schizophrenia Disorders in 23,660 participants. Not yet recruiting.
21 September 2026
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 23,660 |
| Start date | 2 February 2025 |
| Primary completion | 21 September 2026 |
| Estimated completion | 21 September 2026 |
| Sites | 1 location across France |
Conditions studied
- Schizophrenia Disorders — all drugs for Schizophrenia Disorders →
- Bipolar Disorders — all drugs for Bipolar Disorders →
- Major Depression — all drugs for Major Depression →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
Adults 18 to 65, any sex, with Schizophrenia Disorders or Bipolar Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. MonPsy\&Moi®, a digital platform funded by ATIH and DGOS, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across France. The study consists of two stages: Stage 1 (No Feedback): MonPsy\&Moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. Objectives include assessing implementation feasibility, validating adaptive questionnaires (PREMIUM), and identifying predictors of patient outcomes, such as relapse and healthcare utilization. Stage 2 (With Feedback): Focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). This stage evaluates the impact of providing PREMs/PROMs feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes. MonPsy\&Moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. It also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. The platform integrates with national healthcare databases (SNDS) to enhance data analysis and predict patient trajectories. The study will involve over 22,000 participants in Stage 1 and 1,100 participants in Stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. Results aim to demonstrate the feasibility, acceptability, and efficacy of MonPsy\&Moi® in improving mental health outcomes and guiding national psychiatric care policies. By empowering patients and clinicians with actionable insights, MonPsy\&Moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06818227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06818227 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 10 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06818227.
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