Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
9 april 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
636
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alzey, Duitsland
- Ingetrokken
- Rheinhessen-Fachklinik Alzey
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Berlin, Duitsland
- Ingetrokken
- Vivantes Klinikum
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Dusseldorf, Duitsland
- Ingetrokken
- LVR- Klinikum Düsseldorf
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Homburg, Duitsland
- Ingetrokken
- Universitätsklinikum des Saarlandes
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Magdeburg, Duitsland
- Ingetrokken
- Universitätsklinikum Magdeburg
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Taufkirchen, Duitsland
- Ingetrokken
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Clamart, Frankrijk
- Ingetrokken
- H. Paul-Guiraud Clamart
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Jonzac, Frankrijk
- Ingetrokken
- CH Jonzac
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Laxou, Frankrijk
- Ingetrokken
- Centre Psychotherapique Nancy
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Limoges, Frankrijk
- Ingetrokken
- Centre Hospitalier Esquirol
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Montpellier, Frankrijk
- Werving
- CHS-La Colombière
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Nantes, Frankrijk
- Ingetrokken
- CHU Nantes Hospital Saint Jacques
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Nice, Frankrijk
- Ingetrokken
- CH Sainte Marie
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Nice, Frankrijk
- Werving
- CHU Pasteur
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Paris, Frankrijk
- Werving
- Hospital Maison Blanche XX Bichat
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Paris, Frankrijk
- Ingetrokken
- Hospital SAINTE ANNE
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Poitiers, Frankrijk
- Werving
- Centre Hospitalier Henri Laborit
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Rennes, Frankrijk
- Werving
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, Frankrijk
- Werving
- CHU-Saint Etienne
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Saint-Egreve, Frankrijk
- Ingetrokken
- Centre Hospitalier Alpes Isère
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Toulon, Frankrijk
- Ingetrokken
- CHITS - Hôpital Chalucet
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Vesoul, Frankrijk
- Ingetrokken
- CHS St. Remy
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Ancona, Italië
- Werving
- Ospedali Riuniti di Ancona
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Bari, Italië
- Werving
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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Camaiore, Italië
- Werving
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Italië
- Nog niet aan het werven
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Italië
- Werving
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Italië
- Werving
- Mental Health Department (MDSM) ASP di Messina
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Milan, Italië
- Werving
- Ospedale Niguarda
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Modena, Italië
- Werving
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Italië
- Werving
- Centro Salute Mentale di Pesaro
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Roma, Italië
- Werving
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Italië
- Nog niet aan het werven
- Fondazione PTV Policlinico Tor Vergara
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Rome, Italië
- Werving
- Villa Maria Dia Hospital
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Salerno, Italië
- Werving
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Italië
- Werving
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Italië
- Werving
- Centro di Salute Mentale
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San Benedetto del Tronto, Italië
- Werving
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Italië
- Werving
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Italië
- Werving
- ASL di Teramo
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Alcala de Henares, Spanje
- Ingetrokken
- Hospital Príncipe de Asturias
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Barcelona, Spanje
- Werving
- Hospital de Sant Pau
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Barcelona, Spanje
- Werving
- Hospital del Mar
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Barcelona, Spanje
- Ingetrokken
- Hospital Clínic de Barcelona
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Barcelona, Spanje
- Werving
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, Spanje
- Werving
- Hospital Universitario de Cruces
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Girona, Spanje
- Werving
- Hospital santa Caterina -IAS
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Granada, Spanje
- Werving
- Hospital Campus de la Salud
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Huelva, Spanje
- Ingetrokken
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, Spanje
- Werving
- Hospital de Jerez
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L'Hospitalet de Llobregat, Spanje
- Werving
- Hospital Universitari de Bellvitge
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Madrid, Spanje
- Werving
- Hospital Universitario 12 de Octubre
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Madrid, Spanje
- Werving
- Hospital Fundación Jiménez Díaz
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Madrid, Spanje
- Ingetrokken
- Hospital Clinico San Carlos
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Malaga, Spanje
- Ingetrokken
- Hermanas Hospitalarias de Málaga
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Murcia, Spanje
- Ingetrokken
- Hospital General Universitario Morales Meseguer
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Palma, Spanje
- Werving
- Hospital Son Espases
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Sabadell, Spanje
- Ingetrokken
- Hospital Parc Tauli
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Sant Boi de Llobregat, Spanje
- Werving
- Hospital Sant Joan de Déu de Sant Boi
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Santander, Spanje
- Werving
- Hospital Marqués de Valdecilla
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Toledo, Spanje
- Werving
- Hospital Provincial de Toledo
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Valencia, Spanje
- Ingetrokken
- Hospital Clinico Universitario de Valencia
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Valencia, Spanje
- Ingetrokken
- Hospital Universitari i Politecnic La Fe
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Vic, Spanje
- Werving
- Hospital de Vic
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Vigo, Spanje
- Werving
- Hospital Alvaro Cunqueiro
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Zamora, Spanje
- Ingetrokken
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, Spanje
- Werving
- Hospital Punta de Europa
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 35 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
13 juli 2017
Primaire voltooiing (Verwacht)
31 januari 2020
Studie voltooiing (Verwacht)
31 januari 2020
Studieregistratiedata
Eerst ingediend
21 april 2017
Eerst ingediend dat voldeed aan de QC-criteria
21 april 2017
Eerst geplaatst (Werkelijk)
26 april 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 april 2019
Laatste update ingediend die voldeed aan QC-criteria
9 april 2019
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 031-303-00136
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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