Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia

Last updated: April 9, 2019
Sponsor: Otsuka Pharmaceutical Europe Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psychosis

Mood Disorders

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT03130465
031-303-00136
  • Ages 18-35
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients between ≥18 and ≤35 years of age

  2. Diagnosis of schizophrenia confirmed by the current investigator.

  3. Initiation of maintenance treatment with AOM (at least one injection) or with dailyoral atypical AP before the study start at the site and up to a maximum of 6 monthsafter the launch of AOM in the country, during an inpatient stay due to an acuteschizophrenia episode or during the immediate three months after hospital discharge,and prescribed in the usual manner in accordance with the terms of the marketingauthorisation.* Patients treated in the daycare hospital will be considered:

  • Eligible to be included, if the patient was admitted in the hospital (full timeinpatient stay) for an acute psychotic episode and then discharged to a day carehospital in order to achieve stabilization and initiate maintenance antipsychotictreatment. The initiation of the maintenance antipsychotic treatment (index date)must occur before discharge from day care hospital or during the immediatefollowing three months after discharge.

  • NOT eligible, if the patient was treated exclusively in the day care hospitalsince the first day (i.e. not spending any night at all in the hospital) as thesepatients are very likely to be subacutely psychotic.

  • The date of initiation of maintenance therapy will be considered the indexdate. For AOM, it is the date of the first injection. For the oral AP, thisdate is defined by the physician when patients are believed to be stableenough to be considered "in maintenance treatment".

  1. Willingness to participate in the study; subjects must give their written consent toparticipate unless: they have discontinued treatment or have finished the 12 monthsfollow up period before study inclusion (retrospective assessment only) and a) writtenconsent not required by local regulations, or b) it would take a non-reasonableeffort† or c) the source patient is deceased or untraceable.
  • A reasonable effort is defined as 3 contact attempts separated by 3 weeks. Allefforts to obtain the informed consent, reasonable or not, shall be registered inthe 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 assessmentonly.

Exclusion

Exclusion Criteria:

  1. The patient has a psychiatric disorder other than schizophrenia which is establishedas the primary diagnosis

  2. Chronically hospitalized patients (defined as more than 3 months).

  3. Participation in an interventional clinical trial since AOM or daily oral atypical APwere initiated as maintenance treatment or within the previous 6 months to thisinitiation.

Study Design

Total Participants: 636
Study Start date:
July 13, 2017
Estimated Completion Date:
January 31, 2020

Study 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.

Connect with a study center

  • EPSM in the SARTHE

    Allonnes,
    France

    Site Not Available

  • H. Paul-Guiraud Clamart

    Clamart,
    France

    Site Not Available

  • CH Jonzac

    Jonzac,
    France

    Site Not Available

  • Centre Psychotherapique Nancy

    Laxou,
    France

    Site Not Available

  • Centre Hospitalier Esquirol

    Limoges,
    France

    Site Not Available

  • CHU La Conception

    Marseille,
    France

    Site Not Available

  • CHS-La Colombière

    Montpellier,
    France

    Active - Recruiting

  • CHU Nantes Hospital Saint Jacques

    Nantes,
    France

    Site Not Available

  • CH Sainte Marie

    Nice,
    France

    Site Not Available

  • CHU Pasteur

    Nice,
    France

    Active - Recruiting

  • Hospital Maison Blanche XX Bichat

    Paris,
    France

    Active - Recruiting

  • Hospital Sainte Anne

    Paris,
    France

    Site Not Available

  • Centre Hospitalier Henri laborit

    Poitiers,
    France

    Active - Recruiting

  • Centre Hospitalier Gillaume regnier-CHGR

    Rennes,
    France

    Active - Recruiting

  • CHU-Saint Etienne

    Saint Etienne,
    France

    Active - Recruiting

  • Centre Hospitalier Alpes Isere

    Saint-Egreve,
    France

    Site Not Available

  • CHITS - Hôpital Chalucet

    Toulon,
    France

    Site Not Available

  • CHS St. Remy

    Vesoul,
    France

    Site Not Available

  • Rheinhessen-Fachklinik Alzey

    Alzey,
    Germany

    Site Not Available

  • Vivantes Klinikum

    Berlin,
    Germany

    Site Not Available

  • LVR- Klinikum Düsseldorf

    Dusseldorf,
    Germany

    Site Not Available

  • Universitätsklinikum des Saarlandes

    Homburg,
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg

    Magdeburg,
    Germany

    Site Not Available

  • Kbo-Isar-Ampere-Klinikum Taufkirchen

    Taufkirchen,
    Germany

    Site Not Available

  • Ospedali Riuniti di Ancona

    Ancona,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    Bari,
    Italy

    Active - Recruiting

  • Ospedale Versilia di Camaiore

    Camaiore,
    Italy

    Active - Recruiting

  • Cura Neuropsichiatria Villa Von Siebenthal

    Genzano Di Roma,
    Italy

    Site Not Available

  • P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura

    Giulianova,
    Italy

    Active - Recruiting

  • Mental Health Department (MDSM) ASP di Messina

    Messina,
    Italy

    Active - Recruiting

  • Ospedale Niguarda

    Milan,
    Italy

    Active - Recruiting

  • Dipartimento di Salute Mentale -ASL Modena

    Modena,
    Italy

    Active - Recruiting

  • Centro Salute Mentale di Pesaro

    Pesaro,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria

    Roma,
    Italy

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergara

    Roma,
    Italy

    Site Not Available

  • Villa Maria Dia Hospital

    Rome,
    Italy

    Active - Recruiting

  • Unit Mental Health District Nº72- ASL Salerno

    Salerno,
    Italy

    Active - Recruiting

  • Unita Operativa- Salute Mentale di Salerno

    Salerno,
    Italy

    Active - Recruiting

  • Centro di Salute Mentale

    Saluzzo,
    Italy

    Active - Recruiting

  • Ospedale Madonna del Soccorso San Bendedetto del Tronto

    San Benedetto del Tronto,
    Italy

    Active - Recruiting

  • Dipartimento di Salute Mentale- ASL Napoli

    San Giorgio a Cremano,
    Italy

    Active - Recruiting

  • ASL di Teramo

    Teramo,
    Italy

    Active - Recruiting

  • Hospital Punta de Europa

    Algeciras, Cadiz
    Spain

    Active - Recruiting

  • Hospital Príncipe de Asturias

    Alcala de Henares,
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital de Sant pau

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona,
    Spain

    Active - Recruiting

  • IINA (Instituto Internacional de Neurociencias Aplicadas)

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Bilbao,
    Spain

    Active - Recruiting

  • Hospital santa Caterina -IAS

    Girona,
    Spain

    Active - Recruiting

  • Hospital Campus de la Salud

    Granada,
    Spain

    Active - Recruiting

  • Hospital Juan Ramón Jiménez

    Huelva,
    Spain

    Site Not Available

  • Hospital de Jerez

    Jerez de la Frontera,
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat,
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Fundación Jiménez Díaz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hermanas Hospitalarias de Málaga

    Malaga,
    Spain

    Site Not Available

  • Hospital General Universitario Morales Meseguer

    Murcia,
    Spain

    Site Not Available

  • Hospital Son Espases

    Palma,
    Spain

    Active - Recruiting

  • Hospital Parc Taulí

    Sabadell,
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu de Sant Boi

    Sant Boi de Llobregat,
    Spain

    Active - Recruiting

  • Hospital Marqués de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Provincial de Toledo

    Toledo,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital de Vic

    Vic,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo,
    Spain

    Active - Recruiting

  • Hospital Provincial de Zamora

    Zamora,
    Spain

    Site Not Available

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