Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- NCT03130465
- Lead Sponsor
- Otsuka Pharmaceutical Europe Ltd
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 636
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP 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).
- Secondary Outcome Measures
Name Time Method Change over time in CGI-S (score) 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.
Change over time in QLS-5 (score) 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.
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation 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.
Relapse rate (%) in the first 12 months after initiation of maintenance treatment 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.
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) 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.
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) 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.
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures) 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.
Trial Locations
- Locations (67)
Centre Psychotherapique Nancy
🇫🇷Laxou, France
Centre Hospitalier Esquirol
🇫🇷Limoges, France
H. Paul-Guiraud Clamart
🇫🇷Clamart, France
CH Jonzac
🇫🇷Jonzac, France
CHS-La Colombière
🇫🇷Montpellier, France
CH Sainte Marie
🇫🇷Nice, France
Hospital Maison Blanche XX Bichat
🇫🇷Paris, France
Hospital Sainte Anne
🇫🇷Paris, France
CHU Pasteur
🇫🇷Nice, France
Centre Hospitalier Alpes Isere
🇫🇷Saint-Egreve, France
CHU-Saint Etienne
🇫🇷Saint Etienne, France
CHS St. Remy
🇫🇷Vesoul, France
Rheinhessen-Fachklinik Alzey
🇩🇪Alzey, Germany
Vivantes Klinikum
🇩🇪Berlin, Germany
LVR- Klinikum Düsseldorf
🇩🇪Dusseldorf, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Kbo-Isar-Ampere-Klinikum Taufkirchen
🇩🇪Taufkirchen, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Ospedale Versilia di Camaiore
🇮🇹Camaiore, Italy
Mental Health Department (MDSM) ASP di Messina
🇮🇹Messina, Italy
Centro Salute Mentale di Pesaro
🇮🇹Pesaro, Italy
Dipartimento di Salute Mentale -ASL Modena
🇮🇹Modena, Italy
Ospedale Madonna del Soccorso San Bendedetto del Tronto
🇮🇹San Benedetto del Tronto, Italy
Hermanas Hospitalarias de Málaga
🇪🇸Malaga, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Provincial de Toledo
🇪🇸Toledo, Spain
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
🇮🇹Bari, Italy
Cura Neuropsichiatria Villa Von Siebenthal
🇮🇹Genzano Di Roma, Italy
P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
🇮🇹Giulianova, Italy
Ospedale Niguarda
🇮🇹Milan, Italy
Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
🇮🇹Roma, Italy
Fondazione PTV Policlinico Tor Vergara
🇮🇹Roma, Italy
Villa Maria Dia Hospital
🇮🇹Rome, Italy
Unit Mental Health District Nº72- ASL Salerno
🇮🇹Salerno, Italy
Unita Operativa- Salute Mentale di Salerno
🇮🇹Salerno, Italy
Centro di Salute Mentale
🇮🇹Saluzzo, Italy
Dipartimento di Salute Mentale- ASL Napoli
🇮🇹San Giorgio a Cremano, Italy
CHU Nantes Hospital Saint Jacques
🇫🇷Nantes, France
Centre Hospitalier Henri laborit
🇫🇷Poitiers, France
Centre Hospitalier Gillaume regnier-CHGR
🇫🇷Rennes, France
CHITS - Hôpital Chalucet
🇫🇷Toulon, France
Hospital Punta de Europa
🇪🇸Algeciras, Cadiz, Spain
IINA (Instituto Internacional de Neurociencias Aplicadas)
🇪🇸Barcelona, Spain
ASL di Teramo
🇮🇹Teramo, Italy
Hospital Príncipe de Asturias
🇪🇸Alcala de Henares, Spain
Hospital Son Espases
🇪🇸Palma, Spain
Hospital Parc Taulí
🇪🇸Sabadell, Spain
Hospital de Sant pau
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital santa Caterina -IAS
🇪🇸Girona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de Cruces
🇪🇸Bilbao, Spain
Hospital Campus de la Salud
🇪🇸Granada, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Spain
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Sant Joan de Déu de Sant Boi
🇪🇸Sant Boi de Llobregat, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Provincial de Zamora
🇪🇸Zamora, Spain
Hospital de Vic
🇪🇸Vic, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain