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Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

Study acronym: PEPsy-CM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 2 of 6 sites Publications: details revised at 1 of 1 entryv6 Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  2. Secondary endpoints: details revised at 7 of 194 entries Site contacts updated at 2 of 6 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 2 of 6 sites
  3. Primary completion date: Sep 2026 to Sep 2028 Study sites: 7 to 6 · Completion date: Nov 2026 to Nov 2028v4 Show 2 more changesShow less
    • Study sites: 7 to 6
    • Completion date: Nov 2026 to Nov 2028
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Nov 2026 to Sep 2026 · Start date changed from estimate of Nov 2021 to Sep 27, 2021 · Site details revised at 7 of 7 sitesv2 Show 3 more changesShow less
    • Primary completion date: Nov 2026 to Sep 2026
    • Start date changed from estimate of Nov 2021 to Sep 27, 2021
    • Site details revised at 7 of 7 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration
Trial Details
NCT Number NCT05116514
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Psychotic Episode
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov