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

NCT03130465 | Unknown

• 1 other identifier: 031-303-00136
• Study Type: observational
• Target: 636
• Locations: 4 countries
• Sites: 67

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.

Conditions

Schizophrenia

Keywords

adherence; long-acting injectable antipsychotic; all-cause treatment discontinuation; recent-onset schizophrenia; daily oral atypical antipsychotic

Outcome Measures

Primary Outcomes (1)

• Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP

  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

Secondary Outcomes (7)

• Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation

  First 12 months after initiation of maintenance treatment

• Relapse rate (%) in the first 12 months after initiation of maintenance treatment

  First 12 months after initiation of maintenance treatment

• Change over time in CGI-S (score)

  From index date up to a maximun of 12 months

• Change over time in QLS-5 (score)

  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)

  From index date up to a maximun of 12 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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".
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Europe Ltd: lead
• H. Lundbeck A/S: collaborator

Study Sites (67)

H. Paul-Guiraud Clamart

Clamart, France

WITHDRAWN

CH Jonzac

Jonzac, France

WITHDRAWN

Centre Psychotherapique Nancy

Laxou, France

WITHDRAWN

Centre Hospitalier Esquirol

Limoges, France

WITHDRAWN

CHS-La Colombière

Montpellier, France

RECRUITING

CHU Nantes Hospital Saint Jacques

Nantes, France

WITHDRAWN

CH Sainte Marie

Nice, France

WITHDRAWN

CHU Pasteur

Nice, France

RECRUITING

Hospital Maison Blanche XX Bichat

Paris, France

RECRUITING

Hospital Sainte Anne

Paris, France

WITHDRAWN

Centre Hospitalier Henri laborit

Poitiers, France

RECRUITING

Centre Hospitalier Gillaume regnier-CHGR

Rennes, France

RECRUITING

CHU-Saint Etienne

Saint-Etienne, France

RECRUITING

Centre Hospitalier Alpes Isere

Saint-Égrève, France

WITHDRAWN

CHITS - Hôpital Chalucet

Toulon, France

WITHDRAWN

CHS St. Remy

Vesoul, France

WITHDRAWN

Rheinhessen-Fachklinik Alzey

Alzey, Germany

WITHDRAWN

Vivantes Klinikum

Berlin, Germany

WITHDRAWN

LVR- Klinikum Düsseldorf

Düsseldorf, Germany

WITHDRAWN

Universitätsklinikum des Saarlandes

Homburg, Germany

WITHDRAWN

Universitätsklinikum Magdeburg

Magdeburg, Germany

WITHDRAWN

Kbo-Isar-Ampere-Klinikum Taufkirchen

Taufkirchen, Germany

WITHDRAWN

Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, Italy

RECRUITING

Ospedale Versilia di Camaiore

Camaiore, Italy

RECRUITING

Cura Neuropsichiatria Villa Von Siebenthal

Genzano di Roma, Italy

NOT YET RECRUITING

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

Giulianova, Italy

RECRUITING

Mental Health Department (MDSM) ASP di Messina

Messina, Italy

RECRUITING

Ospedale Niguarda

Milan, Italy

RECRUITING

Dipartimento di Salute Mentale -ASL Modena

Modena, Italy

RECRUITING

Centro Salute Mentale di Pesaro

Pesaro, Italy

RECRUITING

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

Roma, Italy

RECRUITING

Fondazione PTV Policlinico Tor Vergara

Roma, Italy

NOT YET RECRUITING

Villa Maria Dia Hospital

Rome, Italy

RECRUITING

Unit Mental Health District Nº72- ASL Salerno

Salerno, Italy

RECRUITING

Unita Operativa- Salute Mentale di Salerno

Salerno, Italy

RECRUITING

Centro di Salute Mentale

Saluzzo, Italy

RECRUITING

Ospedale Madonna del Soccorso San Bendedetto del Tronto

San Benedetto del Tronto, Italy

RECRUITING

Dipartimento di Salute Mentale- ASL Napoli

San Giorgio a Cremano, Italy

RECRUITING

ASL di Teramo

Teramo, Italy

RECRUITING

Hospital Punta de Europa

Algeciras, Cadiz, Spain

RECRUITING

Hospital Príncipe de Asturias

Alcalá de Henares, Spain

WITHDRAWN

Hospital Clínic de Barcelona

Barcelona, Spain

WITHDRAWN

Hospital de Sant pau

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

IINA (Instituto Internacional de Neurociencias Aplicadas)

Barcelona, Spain

RECRUITING

Hospital Universitario de Cruces

Bilbao, Spain

RECRUITING

Hospital santa Caterina -IAS

Girona, Spain

RECRUITING

Hospital Campus de la Salud

Granada, Spain

RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Spain

WITHDRAWN

Hospital de Jerez

Jerez de la Frontera, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

WITHDRAWN

Hospital Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hermanas Hospitalarias de Málaga

Málaga, Spain

WITHDRAWN

Hospital General Universitario Morales Meseguer

Murcia, Spain

WITHDRAWN

Hospital Son Espases

Palma, Spain

RECRUITING

Hospital Parc Taulí

Sabadell, Spain

WITHDRAWN

Hospital Sant Joan de Déu de Sant Boi

Sant Boi de Llobregat, Spain

RECRUITING

Hospital Marqués de Valdecilla

Santander, Spain

RECRUITING

Hospital Provincial de Toledo

Toledo, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

WITHDRAWN

Hospital Universitari i Politècnic La Fe

Valencia, Spain

WITHDRAWN

Hospital de Vic

Vic, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Spain

RECRUITING

Hospital Provincial de Zamora

Zamora, Spain

WITHDRAWN

Related Publications (1)

• 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.

  PMID: 34592798 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Department

  Otsuka Europe

  STUDY DIRECTOR

Central Study Contacts

Jing Wang-Silvanto, PhD

CONTACT

+44 (0) 2037475000; jwang-silvanto@otsuka-europe.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: July 13, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (18); FR (16); DE (6); ES (27)