- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03130465
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
Przegląd badań
Status
Warunki
Szczegółowy opis
This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.
The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Clamart, Francja
- Wycofane
- H. Paul-Guiraud Clamart
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Jonzac, Francja
- Wycofane
- CH Jonzac
-
Laxou, Francja
- Wycofane
- Centre Psychotherapique Nancy
-
Limoges, Francja
- Wycofane
- Centre Hospitalier Esquirol
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Montpellier, Francja
- Rekrutacyjny
- CHS-La Colombière
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Nantes, Francja
- Wycofane
- CHU Nantes Hospital Saint Jacques
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Nice, Francja
- Wycofane
- CH Sainte Marie
-
Nice, Francja
- Rekrutacyjny
- Chu Pasteur
-
Paris, Francja
- Rekrutacyjny
- Hospital Maison Blanche XX Bichat
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Paris, Francja
- Wycofane
- Hospital Sainte Anne
-
Poitiers, Francja
- Rekrutacyjny
- Centre Hospitalier Henri Laborit
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Rennes, Francja
- Rekrutacyjny
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, Francja
- Rekrutacyjny
- CHU-Saint Etienne
-
Saint-Egreve, Francja
- Wycofane
- Centre Hospitalier Alpes Isère
-
Toulon, Francja
- Wycofane
- CHITS - Hôpital Chalucet
-
Vesoul, Francja
- Wycofane
- CHS St. Remy
-
-
-
-
-
Alcala de Henares, Hiszpania
- Wycofane
- Hospital Principe de Asturias
-
Barcelona, Hiszpania
- Rekrutacyjny
- Hospital de Sant Pau
-
Barcelona, Hiszpania
- Rekrutacyjny
- Hospital del Mar
-
Barcelona, Hiszpania
- Wycofane
- Hospital Clinic de Barcelona
-
Barcelona, Hiszpania
- Rekrutacyjny
- IINA (Instituto Internacional de Neurociencias Aplicadas)
-
Bilbao, Hiszpania
- Rekrutacyjny
- Hospital Universitario de Cruces
-
Girona, Hiszpania
- Rekrutacyjny
- Hospital santa Caterina -IAS
-
Granada, Hiszpania
- Rekrutacyjny
- Hospital Campus de la Salud
-
Huelva, Hiszpania
- Wycofane
- Hospital Juan Ramón Jimenez
-
Jerez de la Frontera, Hiszpania
- Rekrutacyjny
- Hospital de Jeréz
-
L'Hospitalet de Llobregat, Hiszpania
- Rekrutacyjny
- Hospital Universitari de Bellvitge
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Madrid, Hiszpania
- Rekrutacyjny
- Hospital Universitario 12 de Octubre
-
Madrid, Hiszpania
- Rekrutacyjny
- Hospital Fundacion Jimenez Diaz
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Madrid, Hiszpania
- Wycofane
- Hospital Clinico San Carlos
-
Malaga, Hiszpania
- Wycofane
- Hermanas Hospitalarias de Málaga
-
Murcia, Hiszpania
- Wycofane
- Hospital General Universitario Morales Meseguer
-
Palma, Hiszpania
- Rekrutacyjny
- Hospital Son Espases
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Sabadell, Hiszpania
- Wycofane
- Hospital Parc Tauli
-
Sant Boi de Llobregat, Hiszpania
- Rekrutacyjny
- Hospital Sant Joan de Déu de Sant Boi
-
Santander, Hiszpania
- Rekrutacyjny
- Hospital Marques de Valdecilla
-
Toledo, Hiszpania
- Rekrutacyjny
- Hospital Provincial de Toledo
-
Valencia, Hiszpania
- Wycofane
- Hospital Clinico Universitario de Valencia
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Valencia, Hiszpania
- Wycofane
- Hospital Universitari i Politecnic La Fe
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Vic, Hiszpania
- Rekrutacyjny
- Hospital de Vic
-
Vigo, Hiszpania
- Rekrutacyjny
- Hospital Alvaro Cunqueiro
-
Zamora, Hiszpania
- Wycofane
- Hospital Provincial de Zamora
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-
Cadiz
-
Algeciras, Cadiz, Hiszpania
- Rekrutacyjny
- Hospital Punta de Europa
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-
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-
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Alzey, Niemcy
- Wycofane
- Rheinhessen-Fachklinik Alzey
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Berlin, Niemcy
- Wycofane
- Vivantes Klinikum
-
Dusseldorf, Niemcy
- Wycofane
- LVR- Klinikum Düsseldorf
-
Homburg, Niemcy
- Wycofane
- Universitatsklinikum des Saarlandes
-
Magdeburg, Niemcy
- Wycofane
- Universitätsklinikum Magdeburg
-
Taufkirchen, Niemcy
- Wycofane
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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-
-
-
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Ancona, Włochy
- Rekrutacyjny
- Ospedali Riuniti di Ancona
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Bari, Włochy
- Rekrutacyjny
- Azienda ospedaliero-universitaria consorziale policlinico di Bari
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Camaiore, Włochy
- Rekrutacyjny
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Włochy
- Jeszcze nie rekrutacja
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Włochy
- Rekrutacyjny
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Włochy
- Rekrutacyjny
- Mental Health Department (MDSM) ASP di Messina
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Milan, Włochy
- Rekrutacyjny
- Ospedale Niguarda
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Modena, Włochy
- Rekrutacyjny
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Włochy
- Rekrutacyjny
- Centro Salute Mentale di Pesaro
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Roma, Włochy
- Rekrutacyjny
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Włochy
- Jeszcze nie rekrutacja
- Fondazione PTV Policlinico Tor Vergara
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Rome, Włochy
- Rekrutacyjny
- Villa Maria Dia Hospital
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Salerno, Włochy
- Rekrutacyjny
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Włochy
- Rekrutacyjny
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Włochy
- Rekrutacyjny
- Centro di Salute Mentale
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San Benedetto del Tronto, Włochy
- Rekrutacyjny
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Włochy
- Rekrutacyjny
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Włochy
- Rekrutacyjny
- ASL di Teramo
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Adult patients between ≥18 and ≤35 years of age
- Diagnosis of schizophrenia confirmed by the current investigator.
Initiation of maintenance treatment with AOM (at least one injection) or with daily oral atypical AP before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country, during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge, and prescribed in the usual manner in accordance with the terms of the marketing authorisation.*
Patients treated in the daycare hospital will be considered:
- Eligible to be included, if the patient was admitted in the hospital (full time inpatient stay) for an acute psychotic episode and then discharged to a day care hospital in order to achieve stabilization and initiate maintenance antipsychotic treatment. The initiation of the maintenance antipsychotic treatment (index date) must occur before discharge from day care hospital or during the immediate following three months after discharge.
NOT eligible, if the patient was treated exclusively in the day care hospital since the first day (i.e. not spending any night at all in the hospital) as these patients are very likely to be subacutely psychotic.
- The date of initiation of maintenance therapy will be considered the index date. For AOM, it is the date of the first injection. For the oral AP, this date is defined by the physician when patients are believed to be stable enough to be considered "in maintenance treatment".
Willingness to participate in the study; subjects must give their written consent to participate unless: they have discontinued treatment or have finished the 12 months follow up period before study inclusion (retrospective assessment only) and a) written consent not required by local regulations, or b) it would take a non-reasonable effort† or c) the source patient is deceased or untraceable.
- A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.
If allowable by local regulations/Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.
Exclusion Criteria:
- The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
- Chronically hospitalized patients (defined as more than 3 months).
- Participation in an interventional clinical trial since AOM or daily oral atypical AP were initiated as maintenance treatment or within the previous 6 months to this initiation.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
---|
Aripiprazole Once Monthly (AOM)
Schizophrenia patients who initiated maintenance treatment with AOM during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
|
Daily oral atypical AP
Schizophrenia patients who initiated maintenance treatment with any daily oral atypical AP during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Ramy czasowe: First 12 months after initiation of maintenance treatment
|
Treatment discontinuation is defined as the interruption, replacement or addition of a new antipsychotic drug to the main antipsychotic initiated at index date (AOM or daily oral atypical AP).
|
First 12 months after initiation of maintenance treatment
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Ramy czasowe: First 12 months after initiation of maintenance treatment
|
To compare the treatment discontinuation rate and the reasons for this discontinuation during the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
|
First 12 months after initiation of maintenance treatment
|
Relapse rate (%) in the first 12 months after initiation of maintenance treatment
Ramy czasowe: First 12 months after initiation of maintenance treatment
|
To compare the relapse rate in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
|
First 12 months after initiation of maintenance treatment
|
Change over time in CGI-S (score)
Ramy czasowe: From index date up to a maximun of 12 months
|
To compare the evolution in disease severity according to Clinical Global Impression-Disease Severity (CGI-S) scale from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
|
From index date up to a maximun of 12 months
|
Change over time in QLS-5 (score)
Ramy czasowe: From index date up to a maximun of 12 months
|
To compare the clinical and functional outcomes according to the 5-item Quality of Life Scale for schizophrenia (QLS-5) from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
|
From index date up to a maximun of 12 months
|
All-cause hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first all-cause hospitalisation and length of hospitalisation(admission/discharge dates)
Ramy czasowe: From index date up to a maximun of 12 months
|
To compare all cause hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
|
From index date up to a maximun of 12 months
|
Mental health-related hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first mental health-related hospitalisation and length of mental-health related hospitalisation (admission/discharge dates)
Ramy czasowe: From index date up to a maximun of 12 months
|
To compare mental health-related hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
|
From index date up to a maximun of 12 months
|
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Ramy czasowe: From index date up to a maximun of 12 months
|
To compare the health resource use related to schizophrenia in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
|
From index date up to a maximun of 12 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 031-303-00136
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt urządzenia regulowany przez amerykańską FDA
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