Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
tiistai 9. huhtikuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Odotettu)
636
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Alcala de Henares, Espanja
- Peruutettu
- Hospital Principe de Asturias
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Barcelona, Espanja
- Rekrytointi
- Hospital de Sant Pau
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Barcelona, Espanja
- Rekrytointi
- Hospital del Mar
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Barcelona, Espanja
- Peruutettu
- Hospital Clinic de Barcelona
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Barcelona, Espanja
- Rekrytointi
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, Espanja
- Rekrytointi
- Hospital Universitario de Cruces
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Girona, Espanja
- Rekrytointi
- Hospital santa Caterina -IAS
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Granada, Espanja
- Rekrytointi
- Hospital Campus de la Salud
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Huelva, Espanja
- Peruutettu
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, Espanja
- Rekrytointi
- Hospital de Jeréz
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L'Hospitalet de Llobregat, Espanja
- Rekrytointi
- Hospital Universitari de Bellvitge
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Madrid, Espanja
- Rekrytointi
- Hospital Universitario 12 de Octubre
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Madrid, Espanja
- Rekrytointi
- Hospital Fundación Jimenez Diaz
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Madrid, Espanja
- Peruutettu
- Hospital Clinico San Carlos
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Malaga, Espanja
- Peruutettu
- Hermanas Hospitalarias de Málaga
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Murcia, Espanja
- Peruutettu
- Hospital General Universitario Morales Meseguer
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Palma, Espanja
- Rekrytointi
- Hospital Son Espases
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Sabadell, Espanja
- Peruutettu
- Hospital Parc Tauli
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Sant Boi de Llobregat, Espanja
- Rekrytointi
- Hospital Sant Joan de Déu de Sant Boi
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Santander, Espanja
- Rekrytointi
- Hospital Marques de Valdecilla
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Toledo, Espanja
- Rekrytointi
- Hospital Provincial de Toledo
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Valencia, Espanja
- Peruutettu
- Hospital Clínico Universitario de Valencia
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Valencia, Espanja
- Peruutettu
- Hospital Universitari i Politecnic La Fe
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Vic, Espanja
- Rekrytointi
- Hospital de Vic
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Vigo, Espanja
- Rekrytointi
- Hospital Alvaro Cunqueiro
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Zamora, Espanja
- Peruutettu
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, Espanja
- Rekrytointi
- Hospital Punta de Europa
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Ancona, Italia
- Rekrytointi
- Ospedali Riuniti di Ancona
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Bari, Italia
- Rekrytointi
- Azienda ospedaliero-universitaria consorziale policlinico di Bari
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Camaiore, Italia
- Rekrytointi
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Italia
- Ei vielä rekrytointia
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Italia
- Rekrytointi
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Italia
- Rekrytointi
- Mental Health Department (MDSM) ASP di Messina
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Milan, Italia
- Rekrytointi
- Ospedale Niguarda
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Modena, Italia
- Rekrytointi
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Italia
- Rekrytointi
- Centro Salute Mentale di Pesaro
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Roma, Italia
- Rekrytointi
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Italia
- Ei vielä rekrytointia
- Fondazione PTV Policlinico Tor Vergara
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Rome, Italia
- Rekrytointi
- Villa Maria Dia Hospital
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Salerno, Italia
- Rekrytointi
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Italia
- Rekrytointi
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Italia
- Rekrytointi
- Centro di Salute Mentale
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San Benedetto del Tronto, Italia
- Rekrytointi
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Italia
- Rekrytointi
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Italia
- Rekrytointi
- ASL di Teramo
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Clamart, Ranska
- Peruutettu
- H. Paul-Guiraud Clamart
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Jonzac, Ranska
- Peruutettu
- CH Jonzac
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Laxou, Ranska
- Peruutettu
- Centre Psychotherapique Nancy
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Limoges, Ranska
- Peruutettu
- Centre Hospitalier Esquirol
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Montpellier, Ranska
- Rekrytointi
- CHS-La Colombière
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Nantes, Ranska
- Peruutettu
- CHU Nantes Hospital Saint Jacques
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Nice, Ranska
- Peruutettu
- CH Sainte Marie
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Nice, Ranska
- Rekrytointi
- Chu Pasteur
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Paris, Ranska
- Rekrytointi
- Hospital Maison Blanche XX Bichat
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Paris, Ranska
- Peruutettu
- Hospital Sainte Anne
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Poitiers, Ranska
- Rekrytointi
- Centre Hospitalier Henri Laborit
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Rennes, Ranska
- Rekrytointi
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, Ranska
- Rekrytointi
- CHU-Saint Etienne
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Saint-Egreve, Ranska
- Peruutettu
- Centre Hospitalier Alpes Isère
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Toulon, Ranska
- Peruutettu
- CHITS - Hôpital Chalucet
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Vesoul, Ranska
- Peruutettu
- CHS St. Remy
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Alzey, Saksa
- Peruutettu
- Rheinhessen-Fachklinik Alzey
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Berlin, Saksa
- Peruutettu
- Vivantes Klinikum
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Dusseldorf, Saksa
- Peruutettu
- LVR- Klinikum Düsseldorf
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Homburg, Saksa
- Peruutettu
- Universitatsklinikum des Saarlandes
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Magdeburg, Saksa
- Peruutettu
- Universitätsklinikum Magdeburg
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Taufkirchen, Saksa
- Peruutettu
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 35 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Todennäköisyysnäyte
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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.
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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)
Aikaikkuna: 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)
Aikaikkuna: 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.
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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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
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Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
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Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 13. heinäkuuta 2017
Ensisijainen valmistuminen (Odotettu)
Perjantai 31. tammikuuta 2020
Opintojen valmistuminen (Odotettu)
Perjantai 31. tammikuuta 2020
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 21. huhtikuuta 2017
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 21. huhtikuuta 2017
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 26. huhtikuuta 2017
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 11. huhtikuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 9. huhtikuuta 2019
Viimeksi vahvistettu
Maanantai 1. huhtikuuta 2019
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