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.

Официальное название

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. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.

Обзор

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

Вмешательства

• Другое Case management
  Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

Первичные конечные точки

• Rate of patients with recurrence of psychotic episode at least once between groups [Срок оценки: 3 years]

Вторичные конечные точки (12)

• Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient [Срок оценки: 1 year]
• Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient [Срок оценки: 2 years]
• Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient [Срок оценки: 3 years]
• Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient [Срок оценки: 1 year]
• Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient [Срок оценки: 2 years]
• Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient [Срок оценки: 3 years]
• Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient [Срок оценки: 1 year]
• Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient [Срок оценки: 2 years]
• Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient [Срок оценки: 3 years]
• Percentage per patient of medical and caregiving appointments honored between groups [Срок оценки: Inclusion]
• Percentage per patient of medical and caregiving appointments honored between groups [Срок оценки: 6 months]
• Percentage per patient of medical and caregiving appointments honored between groups [Срок оценки: 1 year]

Критерии участия

Критерии включения

• The patient or their close relative must have given their free and informed consent and signed the consent form
• 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.

Критерии исключения

• The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• CHU de TOULOUSE — Toulouse
• CH Saint Marie Clermont-Ferrand — Clermont-Ferrand
• CHU de Montpellier — Montpellier
• CHU Nice — Nice
• CHU de Nîmes — Nîmes
• Centre Hospitalier Léon-Jean Grégory — Thuir

Публикации

• 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. PMID 40375175

Идентификаторы

NCT: NCT05116514 · PREPS/2018/AS-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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