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

April 9, 2019 updated by: Otsuka Pharmaceutical Europe Ltd

Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
636

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Clamart, France
        • Withdrawn
        • H. Paul-Guiraud Clamart
      • Jonzac, France
        • Withdrawn
        • CH Jonzac
      • Laxou, France
        • Withdrawn
        • Centre Psychotherapique Nancy
      • Limoges, France
        • Withdrawn
        • Centre Hospitalier Esquirol
      • Montpellier, France
        • Recruiting
        • CHS-La Colombière
      • Nantes, France
        • Withdrawn
        • CHU Nantes Hospital Saint Jacques
      • Nice, France
        • Withdrawn
        • CH Sainte Marie
      • Nice, France
        • Recruiting
        • CHU Pasteur
      • Paris, France
        • Recruiting
        • Hospital Maison Blanche XX Bichat
      • Paris, France
        • Withdrawn
        • Hospital SAINTE ANNE
      • Poitiers, France
        • Recruiting
        • Centre Hospitalier Henri Laborit
      • Rennes, France
        • Recruiting
        • Centre Hospitalier Gillaume regnier-CHGR
      • Saint Etienne, France
        • Recruiting
        • CHU-Saint Etienne
      • Saint-Egreve, France
        • Withdrawn
        • Centre Hospitalier Alpes Isère
      • Toulon, France
        • Withdrawn
        • CHITS - Hôpital Chalucet
      • Vesoul, France
        • Withdrawn
        • CHS St. Remy
  • Germany
      • Alzey, Germany
        • Withdrawn
        • Rheinhessen-Fachklinik Alzey
      • Berlin, Germany
        • Withdrawn
        • Vivantes Klinikum
      • Dusseldorf, Germany
        • Withdrawn
        • LVR- Klinikum Düsseldorf
      • Homburg, Germany
        • Withdrawn
        • Universitätsklinikum des Saarlandes
      • Magdeburg, Germany
        • Withdrawn
        • Universitätsklinikum Magdeburg
      • Taufkirchen, Germany
        • Withdrawn
        • Kbo-Isar-Ampere-Klinikum Taufkirchen
  • Italy
      • Ancona, Italy
        • Recruiting
        • Ospedali Riuniti di Ancona
      • Bari, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
      • Camaiore, Italy
        • Recruiting
        • Ospedale Versilia di Camaiore
      • Genzano Di Roma, Italy
        • Not yet recruiting
        • Cura Neuropsichiatria Villa Von Siebenthal
      • Giulianova, Italy
        • Recruiting
        • P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
      • Messina, Italy
        • Recruiting
        • Mental Health Department (MDSM) ASP di Messina
      • Milan, Italy
        • Recruiting
        • Ospedale Niguarda
      • Modena, Italy
        • Recruiting
        • Dipartimento di Salute Mentale -ASL Modena
      • Pesaro, Italy
        • Recruiting
        • Centro Salute Mentale di Pesaro
      • Roma, Italy
        • Recruiting
        • Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
      • Roma, Italy
        • Not yet recruiting
        • Fondazione PTV Policlinico Tor Vergara
      • Rome, Italy
        • Recruiting
        • Villa Maria Dia Hospital
      • Salerno, Italy
        • Recruiting
        • Unit Mental Health District Nº72- ASL Salerno
      • Salerno, Italy
        • Recruiting
        • Unita Operativa- Salute Mentale di Salerno
      • Saluzzo, Italy
        • Recruiting
        • Centro di Salute Mentale
      • San Benedetto del Tronto, Italy
        • Recruiting
        • Ospedale Madonna del Soccorso San Bendedetto del Tronto
      • San Giorgio a Cremano, Italy
        • Recruiting
        • Dipartimento di Salute Mentale- ASL Napoli
      • Teramo, Italy
        • Recruiting
        • ASL di Teramo
  • Spain
      • Alcala de Henares, Spain
        • Withdrawn
        • Hospital Príncipe de Asturias
      • Barcelona, Spain
        • Recruiting
        • Hospital de Sant Pau
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain
        • Withdrawn
        • Hospital Clínic de Barcelona
      • Barcelona, Spain
        • Recruiting
        • IINA (Instituto Internacional de Neurociencias Aplicadas)
      • Bilbao, Spain
        • Recruiting
        • Hospital Universitario de Cruces
      • Girona, Spain
        • Recruiting
        • Hospital santa Caterina -IAS
      • Granada, Spain
        • Recruiting
        • Hospital Campus de la Salud
      • Huelva, Spain
        • Withdrawn
        • Hospital Juan Ramón Jimenez
      • Jerez de la Frontera, Spain
        • Recruiting
        • Hospital de Jerez
      • L'Hospitalet de Llobregat, Spain
        • Recruiting
        • Hospital Universitari de Bellvitge
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Recruiting
        • Hospital Fundación Jiménez Díaz
      • Madrid, Spain
        • Withdrawn
        • Hospital Clinico San Carlos
      • Malaga, Spain
        • Withdrawn
        • Hermanas Hospitalarias de Málaga
      • Murcia, Spain
        • Withdrawn
        • Hospital General Universitario Morales Meseguer
      • Palma, Spain
        • Recruiting
        • Hospital Son Espases
      • Sabadell, Spain
        • Withdrawn
        • Hospital Parc Tauli
      • Sant Boi de Llobregat, Spain
        • Recruiting
        • Hospital Sant Joan de Déu de Sant Boi
      • Santander, Spain
        • Recruiting
        • Hospital Marqués de Valdecilla
      • Toledo, Spain
        • Recruiting
        • Hospital Provincial de Toledo
      • Valencia, Spain
        • Withdrawn
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Withdrawn
        • Hospital Universitari i Politecnic La Fe
      • Vic, Spain
        • Recruiting
        • Hospital de Vic
      • Vigo, Spain
        • Recruiting
        • Hospital Alvaro Cunqueiro
      • Zamora, Spain
        • Withdrawn
        • Hospital Provincial de Zamora
    • Cadiz
      • Algeciras, Cadiz, Spain
        • Recruiting
        • Hospital Punta de Europa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Time Frame: 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).
First 12 months after initiation of maintenance treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Time Frame: 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.
First 12 months after initiation of maintenance treatment
Relapse rate (%) in the first 12 months after initiation of maintenance treatment
Time Frame: 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.
First 12 months after initiation of maintenance treatment
Change over time in CGI-S (score)
Time Frame: 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.
From index date up to a maximun of 12 months
Change over time in QLS-5 (score)
Time Frame: 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.
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)
Time Frame: 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.
From index date up to a maximun of 12 months
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)
Time Frame: 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.
From index date up to a maximun of 12 months
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Time Frame: 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.
From index date up to a maximun of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Europe Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 031-303-00136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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