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.
NCT ID: NCT05116514
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
256 participants
INTERVENTIONAL
2021-09-27
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Case manager group
Case management
Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months
Control
No interventions assigned to this group
Interventions
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Case management
Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months
Eligibility Criteria
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Inclusion Criteria
* The patient must be a member or beneficiary of a health insurance plan
* The patient is available for a 3-year follow-up.
* Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:
* Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
* Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
* A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
* Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
* At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.
Exclusion Criteria
* The subject, or one of the parents for minor patients, refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patients has an IQ less than or equal to 55
* The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
* The patient is pregnant or breastfeeding
16 Years
30 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Aurélie Schandrin
Role: PRINCIPAL_INVESTIGATOR
CHU Nimes
Locations
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CHU de TOULOUSE
Toulouse, Choisir Une Région, France
CH Saint Marie Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Montpellier
Montpellier, , France
CHU Nice
Nice, , France
CHU de Nîmes
Nîmes, , France
Centre Hospitalier Léon-Jean Grégory
Thuir, , France
Countries
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Central Contacts
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Facility Contacts
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ETIENNE VERY
Role: primary
Sébastien ALMON
Role: primary
Delphine CAPDEVIELLE
Role: primary
Bruno GIORDANA
Role: primary
Anissa Megzari
Role: primary
Aurore LARUE
Role: primary
References
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Schandrin A, Jourdan J, Chkair S, Bouvet S, Fabbro-Peray P, Abbar M; PEPsy-CM working group. PEPsy-CM study protocol: impact of a 3-year program for early psychosis based on case-management on relapse rate, a French multicenter randomized trial. BMC Psychiatry. 2025 May 15;25(1):488. doi: 10.1186/s12888-025-06940-y.
Other Identifiers
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PREPS/2018/AS-01
Identifier Type: -
Identifier Source: org_study_id