Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
9. april 2019 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Forventet)
636
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Clamart, Frankrike
- Tilbaketrukket
- H. Paul-Guiraud Clamart
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Jonzac, Frankrike
- Tilbaketrukket
- CH Jonzac
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Laxou, Frankrike
- Tilbaketrukket
- Centre Psychotherapique Nancy
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Limoges, Frankrike
- Tilbaketrukket
- Centre Hospitalier Esquirol
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Montpellier, Frankrike
- Rekruttering
- CHS-La Colombière
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Nantes, Frankrike
- Tilbaketrukket
- CHU Nantes Hospital Saint Jacques
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Nice, Frankrike
- Tilbaketrukket
- CH Sainte Marie
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Nice, Frankrike
- Rekruttering
- CHU Pasteur
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Paris, Frankrike
- Rekruttering
- Hospital Maison Blanche XX Bichat
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Paris, Frankrike
- Tilbaketrukket
- Hospital SAINTE ANNE
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Poitiers, Frankrike
- Rekruttering
- Centre Hospitalier Henri Laborit
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Rennes, Frankrike
- Rekruttering
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, Frankrike
- Rekruttering
- CHU-Saint Etienne
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Saint-Egreve, Frankrike
- Tilbaketrukket
- Centre Hospitalier Alpes Isère
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Toulon, Frankrike
- Tilbaketrukket
- CHITS - Hôpital Chalucet
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Vesoul, Frankrike
- Tilbaketrukket
- CHS St. Remy
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Ancona, Italia
- Rekruttering
- Ospedali Riuniti di Ancona
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Bari, Italia
- Rekruttering
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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Camaiore, Italia
- Rekruttering
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Italia
- Har ikke rekruttert ennå
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Italia
- Rekruttering
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Italia
- Rekruttering
- Mental Health Department (MDSM) ASP di Messina
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Milan, Italia
- Rekruttering
- Ospedale Niguarda
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Modena, Italia
- Rekruttering
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Italia
- Rekruttering
- Centro Salute Mentale di Pesaro
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Roma, Italia
- Rekruttering
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Italia
- Har ikke rekruttert ennå
- Fondazione PTV Policlinico Tor Vergara
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Rome, Italia
- Rekruttering
- Villa Maria Dia Hospital
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Salerno, Italia
- Rekruttering
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Italia
- Rekruttering
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Italia
- Rekruttering
- Centro di Salute Mentale
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San Benedetto del Tronto, Italia
- Rekruttering
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Italia
- Rekruttering
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Italia
- Rekruttering
- ASL di Teramo
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Alcala de Henares, Spania
- Tilbaketrukket
- Hospital Príncipe de Asturias
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Barcelona, Spania
- Rekruttering
- Hospital de Sant Pau
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Barcelona, Spania
- Rekruttering
- Hospital del Mar
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Barcelona, Spania
- Tilbaketrukket
- Hospital Clínic de Barcelona
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Barcelona, Spania
- Rekruttering
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, Spania
- Rekruttering
- Hospital Universitario de Cruces
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Girona, Spania
- Rekruttering
- Hospital santa Caterina -IAS
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Granada, Spania
- Rekruttering
- Hospital Campus de la Salud
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Huelva, Spania
- Tilbaketrukket
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, Spania
- Rekruttering
- Hospital de Jerez
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L'Hospitalet de Llobregat, Spania
- Rekruttering
- Hospital Universitari de Bellvitge
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Madrid, Spania
- Rekruttering
- Hospital Universitario 12 de Octubre
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Madrid, Spania
- Rekruttering
- Hospital Fundación Jiménez Díaz
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Madrid, Spania
- Tilbaketrukket
- Hospital Clinico San Carlos
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Malaga, Spania
- Tilbaketrukket
- Hermanas Hospitalarias de Málaga
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Murcia, Spania
- Tilbaketrukket
- Hospital General Universitario Morales Meseguer
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Palma, Spania
- Rekruttering
- Hospital Son Espases
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Sabadell, Spania
- Tilbaketrukket
- Hospital Parc Tauli
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Sant Boi de Llobregat, Spania
- Rekruttering
- Hospital Sant Joan de Déu de Sant Boi
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Santander, Spania
- Rekruttering
- Hospital Marqués de Valdecilla
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Toledo, Spania
- Rekruttering
- Hospital Provincial de Toledo
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Valencia, Spania
- Tilbaketrukket
- Hospital Clinico Universitario de Valencia
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Valencia, Spania
- Tilbaketrukket
- Hospital Universitari i Politecnic La Fe
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Vic, Spania
- Rekruttering
- Hospital de Vic
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Vigo, Spania
- Rekruttering
- Hospital Alvaro Cunqueiro
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Zamora, Spania
- Tilbaketrukket
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, Spania
- Rekruttering
- Hospital Punta de Europa
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Alzey, Tyskland
- Tilbaketrukket
- Rheinhessen-Fachklinik Alzey
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Berlin, Tyskland
- Tilbaketrukket
- Vivantes Klinikum
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Dusseldorf, Tyskland
- Tilbaketrukket
- LVR- Klinikum Düsseldorf
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Homburg, Tyskland
- Tilbaketrukket
- Universitätsklinikum des Saarlandes
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Magdeburg, Tyskland
- Tilbaketrukket
- Universitätsklinikum Magdeburg
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Taufkirchen, Tyskland
- Tilbaketrukket
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 35 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Tidsramme: 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).
|
First 12 months after initiation of maintenance treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Tidsramme: 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.
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First 12 months after initiation of maintenance treatment
|
|
Relapse rate (%) in the first 12 months after initiation of maintenance treatment
Tidsramme: 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.
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First 12 months after initiation of maintenance treatment
|
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Change over time in CGI-S (score)
Tidsramme: 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
|
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Change over time in QLS-5 (score)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. juli 2017
Primær fullføring (Forventet)
31. januar 2020
Studiet fullført (Forventet)
31. januar 2020
Datoer for studieregistrering
Først innsendt
21. april 2017
Først innsendt som oppfylte QC-kriteriene
21. april 2017
Først lagt ut (Faktiske)
26. april 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 031-303-00136
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .