Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
NCT ID: NCT03130465
Last Updated: 2019-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
636 participants
OBSERVATIONAL
2017-07-13
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of schizophrenia confirmed by the current investigator.
3. 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".
4. 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
2. Chronically hospitalized patients (defined as more than 3 months).
3. 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.
18 Years
35 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Europe Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Department
Role: STUDY_DIRECTOR
Otsuka Europe
Locations
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H. Paul-Guiraud Clamart
Clamart, , France
CH Jonzac
Jonzac, , France
Centre Psychotherapique Nancy
Laxou, , France
Centre Hospitalier Esquirol
Limoges, , France
CHS-La Colombière
Montpellier, , France
CHU Nantes Hospital Saint Jacques
Nantes, , France
CH Sainte Marie
Nice, , France
CHU Pasteur
Nice, , France
Hospital Maison Blanche XX Bichat
Paris, , France
Hospital Sainte Anne
Paris, , France
Centre Hospitalier Henri laborit
Poitiers, , France
Centre Hospitalier Gillaume regnier-CHGR
Rennes, , France
CHU-Saint Etienne
Saint-Etienne, , France
Centre Hospitalier Alpes Isere
Saint-Égrève, , France
CHITS - Hôpital Chalucet
Toulon, , France
CHS St. Remy
Vesoul, , France
Rheinhessen-Fachklinik Alzey
Alzey, , Germany
Vivantes Klinikum
Berlin, , Germany
LVR- Klinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
Kbo-Isar-Ampere-Klinikum Taufkirchen
Taufkirchen, , Germany
Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Ospedale Versilia di Camaiore
Camaiore, , 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
Mental Health Department (MDSM) ASP di Messina
Messina, , Italy
Ospedale Niguarda
Milan, , Italy
Dipartimento di Salute Mentale -ASL Modena
Modena, , Italy
Centro Salute Mentale di Pesaro
Pesaro, , 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
Ospedale Madonna del Soccorso San Bendedetto del Tronto
San Benedetto del Tronto, , Italy
Dipartimento di Salute Mentale- ASL Napoli
San Giorgio a Cremano, , Italy
ASL di Teramo
Teramo, , Italy
Hospital Punta de Europa
Algeciras, Cadiz, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de Sant pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
IINA (Instituto Internacional de Neurociencias Aplicadas)
Barcelona, , Spain
Hospital Universitario de Cruces
Bilbao, , Spain
Hospital santa Caterina -IAS
Girona, , 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 Clínico San Carlos
Madrid, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hermanas Hospitalarias de Málaga
Málaga, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Son Espases
Palma, , Spain
Hospital Parc Taulí
Sabadell, , Spain
Hospital Sant Joan de Déu de Sant Boi
Sant Boi de Llobregat, , Spain
Hospital Marqués de Valdecilla
Santander, , Spain
Hospital Provincial de Toledo
Toledo, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hospital de Vic
Vic, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Hospital Provincial de Zamora
Zamora, , Spain
Countries
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Central Contacts
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References
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Such P, Bog M, Kabra MS, Jorgensen KT, de Jong-Laird AC. A Noninterventional Cohort Study Assessing Time to All-Cause Treatment Discontinuation After Initiation of Aripiprazole Once Monthly or Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-Onset Schizophrenia. Prim Care Companion CNS Disord. 2021 Sep 30;23(5):20m02886. doi: 10.4088/PCC.20m02886.
Other Identifiers
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031-303-00136
Identifier Type: -
Identifier Source: org_study_id
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