Clinical trial NCT03130465: Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
Official title: Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: adherence
long-acting injectable antipsychotic
all-cause treatment discontinuation
recent-onset schizophrenia
daily oral atypical antipsychotic
Lead sponsor: Otsuka Pharmaceutical Europe Ltd
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2017-04-26
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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 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:

1. The patient has a psychiatric disorder other than schizophrenia which is established as 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 AP were initiated as maintenance treatment or within the previous 6 months to this initiation.

Primary outcomes:
measure: Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
timeFrame: First 12 months after initiation of maintenance treatment
Secondary outcomes:
measure: Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
timeFrame: First 12 months after initiation of maintenance treatment
measure: Relapse rate (%) in the first 12 months after initiation of maintenance treatment
timeFrame: First 12 months after initiation of maintenance treatment
measure: Change over time in CGI-S (score)
timeFrame: From index date up to a maximun of 12 months
measure: Change over time in QLS-5 (score)
timeFrame: From index date up to a maximun of 12 months
measure: 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)
timeFrame: From index date up to a maximun of 12 months
measure: 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)
timeFrame: From index date up to a maximun of 12 months
measure: Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
timeFrame: From index date up to a maximun of 12 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: H. Paul-Guiraud Clamart
city: Jonzac
country: France
facility: CH Jonzac
city: Laxou
country: France
facility: Centre Psychotherapique Nancy
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Montpellier
country: France
facility: CHS-La Colombière
city: Nantes
country: France
facility: CHU Nantes Hospital Saint Jacques
city: Nice
country: France
facility: CH Sainte Marie
city: Nice
country: France
facility: CHU Pasteur
city: Paris
country: France
facility: Hospital Maison Blanche XX Bichat
city: Paris
country: France
facility: Hospital Sainte Anne
city: Poitiers
country: France
facility: Centre Hospitalier Henri laborit
city: Rennes
country: France
facility: Centre Hospitalier Gillaume regnier-CHGR
city: Saint Etienne
country: France
facility: CHU-Saint Etienne
city: Saint-Egreve
country: France
facility: Centre Hospitalier Alpes Isere
city: Toulon
country: France
facility: CHITS - Hôpital Chalucet
city: Vesoul
country: France
facility: CHS St. Remy
city: Alzey
country: Germany
facility: Rheinhessen-Fachklinik Alzey
city: Berlin
country: Germany
facility: Vivantes Klinikum
city: Dusseldorf
country: Germany
facility: LVR- Klinikum Düsseldorf
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Taufkirchen
country: Germany
facility: Kbo-Isar-Ampere-Klinikum Taufkirchen
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
city: Camaiore
country: Italy
facility: Ospedale Versilia di Camaiore
city: Genzano Di Roma
country: Italy
facility: Cura Neuropsichiatria Villa Von Siebenthal
city: Giulianova
country: Italy
facility: P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
city: Messina
country: Italy
facility: Mental Health Department (MDSM) ASP di Messina
city: Milan
country: Italy
facility: Ospedale Niguarda
city: Modena
country: Italy
facility: Dipartimento di Salute Mentale -ASL Modena
city: Pesaro
country: Italy
facility: Centro Salute Mentale di Pesaro
city: Roma
country: Italy
facility: Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergara
city: Rome
country: Italy
facility: Villa Maria Dia Hospital
city: Salerno
country: Italy
facility: Unit Mental Health District Nº72- ASL Salerno
city: Salerno
country: Italy
facility: Unita Operativa- Salute Mentale di Salerno
city: Saluzzo
country: Italy
facility: Centro di Salute Mentale
city: San Benedetto del Tronto
country: Italy
facility: Ospedale Madonna del Soccorso San Bendedetto del Tronto
city: San Giorgio a Cremano
country: Italy
facility: Dipartimento di Salute Mentale- ASL Napoli
city: Teramo
country: Italy
facility: ASL di Teramo
city: Algeciras
country: Spain
facility: Hospital Punta de Europa
state: Cadiz
city: Alcala de Henares
country: Spain
facility: Hospital Príncipe de Asturias
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sant pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: IINA (Instituto Internacional de Neurociencias Aplicadas)
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
city: Girona
country: Spain
facility: Hospital santa Caterina -IAS
city: Granada
country: Spain
facility: Hospital Campus de la Salud
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hermanas Hospitalarias de Málaga
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Palma
country: Spain
facility: Hospital Son Espases
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
city: Sant Boi de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu de Sant Boi
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Toledo
country: Spain
facility: Hospital Provincial de Toledo
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Vic
country: Spain
facility: Hospital de Vic
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zamora
country: Spain
facility: Hospital Provincial de Zamora
Study officials:
affiliation: Otsuka Europe
name: Medical Department
role: STUDY_DIRECTOR
References:
citation: 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.