Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
9 de abril de 2019 actualizado por: Otsuka Pharmaceutical Europe Ltd
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Anticipado)
636
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jing Wang-Silvanto, PhD
- Número de teléfono: +44 (0) 2037475000
- Correo electrónico: jwang-silvanto@otsuka-europe.com
Ubicaciones de estudio
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Alzey, Alemania
- Retirado
- Rheinhessen-Fachklinik Alzey
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Berlin, Alemania
- Retirado
- Vivantes Klinikum
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Dusseldorf, Alemania
- Retirado
- LVR- Klinikum Düsseldorf
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Homburg, Alemania
- Retirado
- Universitätsklinikum des Saarlandes
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Magdeburg, Alemania
- Retirado
- Universitätsklinikum Magdeburg
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Taufkirchen, Alemania
- Retirado
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Alcala de Henares, España
- Retirado
- Hospital Principe de Asturias
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Barcelona, España
- Reclutamiento
- Hospital de Sant Pau
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Barcelona, España
- Reclutamiento
- Hospital del Mar
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Barcelona, España
- Retirado
- Hospital Clinic de Barcelona
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Barcelona, España
- Reclutamiento
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, España
- Reclutamiento
- Hospital Universitario de Cruces
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Girona, España
- Reclutamiento
- Hospital santa Caterina -IAS
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Granada, España
- Reclutamiento
- Hospital Campus de la Salud
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Huelva, España
- Retirado
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, España
- Reclutamiento
- Hospital de Jerez
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L'Hospitalet de Llobregat, España
- Reclutamiento
- Hospital Universitari de Bellvitge
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Madrid, España
- Reclutamiento
- Hospital Universitario 12 De Octubre
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Madrid, España
- Reclutamiento
- Hospital Fundación Jimenez Diaz
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Madrid, España
- Retirado
- Hospital Clinico San Carlos
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Malaga, España
- Retirado
- Hermanas Hospitalarias de Málaga
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Murcia, España
- Retirado
- Hospital General Universitario Morales Meseguer
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Palma, España
- Reclutamiento
- Hospital Son Espases
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Sabadell, España
- Retirado
- Hospital Parc Tauli
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Sant Boi de Llobregat, España
- Reclutamiento
- Hospital Sant Joan de Déu de Sant Boi
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Santander, España
- Reclutamiento
- Hospital Marques de Valdecilla
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Toledo, España
- Reclutamiento
- Hospital Provincial de Toledo
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Valencia, España
- Retirado
- Hospital Clínico Universitario de Valencia
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Valencia, España
- Retirado
- Hospital Universitari i Politecnic La Fe
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Vic, España
- Reclutamiento
- Hospital de Vic
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Vigo, España
- Reclutamiento
- Hospital Alvaro Cunqueiro
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Zamora, España
- Retirado
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, España
- Reclutamiento
- Hospital Punta de Europa
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Clamart, Francia
- Retirado
- H. Paul-Guiraud Clamart
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Jonzac, Francia
- Retirado
- CH Jonzac
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Laxou, Francia
- Retirado
- Centre Psychotherapique Nancy
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Limoges, Francia
- Retirado
- Centre Hospitalier Esquirol
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Montpellier, Francia
- Reclutamiento
- CHS-La Colombière
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Nantes, Francia
- Retirado
- CHU Nantes Hospital Saint Jacques
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Nice, Francia
- Retirado
- CH Sainte Marie
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Nice, Francia
- Reclutamiento
- Chu Pasteur
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Paris, Francia
- Reclutamiento
- Hospital Maison Blanche XX Bichat
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Paris, Francia
- Retirado
- Hospital Sainte Anne
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Poitiers, Francia
- Reclutamiento
- Centre Hospitalier Henri Laborit
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Rennes, Francia
- Reclutamiento
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, Francia
- Reclutamiento
- CHU-Saint Etienne
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Saint-Egreve, Francia
- Retirado
- Centre Hospitalier Alpes Isère
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Toulon, Francia
- Retirado
- CHITS - Hôpital Chalucet
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Vesoul, Francia
- Retirado
- CHS St. Remy
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Ancona, Italia
- Reclutamiento
- Ospedali Riuniti di Ancona
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Bari, Italia
- Reclutamiento
- Azienda ospedaliero-universitaria consorziale policlinico di Bari
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Camaiore, Italia
- Reclutamiento
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Italia
- Aún no reclutando
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Italia
- Reclutamiento
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Italia
- Reclutamiento
- Mental Health Department (MDSM) ASP di Messina
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Milan, Italia
- Reclutamiento
- Ospedale Niguarda
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Modena, Italia
- Reclutamiento
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Italia
- Reclutamiento
- Centro Salute Mentale di Pesaro
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Roma, Italia
- Reclutamiento
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Italia
- Aún no reclutando
- Fondazione PTV Policlinico Tor Vergara
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Rome, Italia
- Reclutamiento
- Villa Maria Dia Hospital
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Salerno, Italia
- Reclutamiento
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Italia
- Reclutamiento
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Italia
- Reclutamiento
- Centro di Salute Mentale
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San Benedetto del Tronto, Italia
- Reclutamiento
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Italia
- Reclutamiento
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Italia
- Reclutamiento
- ASL di Teramo
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 35 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Eligible patients will include adult patients (≥18 years) with recent-onset (≤35 years old) schizophrenia who initiated maintenance treatment with AOM or an oral atypical AP during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge and which treatment was initiated before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country.
Prescription of the maintenance treatment had to be done in the usual manner in accordance with the terms of the marketing authorisation.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Periodo de tiempo: First 12 months after initiation of maintenance treatment
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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).
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First 12 months after initiation of maintenance treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Periodo de tiempo: First 12 months after initiation of maintenance treatment
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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.
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First 12 months after initiation of maintenance treatment
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Relapse rate (%) in the first 12 months after initiation of maintenance treatment
Periodo de tiempo: First 12 months after initiation of maintenance treatment
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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.
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First 12 months after initiation of maintenance treatment
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Change over time in CGI-S (score)
Periodo de tiempo: From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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Change over time in QLS-5 (score)
Periodo de tiempo: From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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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)
Periodo de tiempo: From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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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)
Periodo de tiempo: From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Periodo de tiempo: 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.
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From index date up to a maximun of 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de julio de 2017
Finalización primaria (Anticipado)
31 de enero de 2020
Finalización del estudio (Anticipado)
31 de enero de 2020
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2017
Primero enviado que cumplió con los criterios de control de calidad
21 de abril de 2017
Publicado por primera vez (Actual)
26 de abril de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
9 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 031-303-00136
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .