SchizophreniaNCT03130465
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
An observational study of Schizophrenia, run by Otsuka Pharmaceutical Europe Ltd at 67 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- Type of treatment
- Pill or oral medicine
- How many people
- 636 participants
- Where
- 67 sitesin 4 countries
- Study dates
- 13 Jul 2017to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
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- 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".
- 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.
Who cannot join
- 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.
Trial locations and contacts
67 sites in 4 countries.
67 sites in 4 countries
Spain27 sites, 17 recruiting
- Withdrawn
Hospital Príncipe de Asturias
Alcalá de Henares
- Recruiting
Hospital Punta de Europa
Algeciras, Cadiz
- Withdrawn
Hospital Clínic de Barcelona
Barcelona
- Recruiting
Hospital de Sant pau
Barcelona
- Recruiting
Hospital del Mar
Barcelona
- Recruiting
IINA (Instituto Internacional de Neurociencias Aplicadas)
Barcelona
- Recruiting
Hospital Universitario de Cruces
Bilbao
- Recruiting
Hospital santa Caterina -IAS
Girona
- Recruiting
Hospital Campus de la Salud
Granada
- Withdrawn
Hospital Juan Ramón Jiménez
Huelva
- Recruiting
Hospital de Jerez
Jerez de la Frontera
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
- Withdrawn
Hospital Clínico San Carlos
Madrid
- Recruiting
Hospital Fundación Jiménez Díaz
Madrid
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
- Withdrawn
Hermanas Hospitalarias de Málaga
Málaga
- Withdrawn
Hospital General Universitario Morales Meseguer
Murcia
- Recruiting
Hospital Son Espases
Palma
- Withdrawn
Hospital Parc Taulí
Sabadell
- Recruiting
Hospital Sant Joan de Déu de Sant Boi
Sant Boi de Llobregat
- Recruiting
Hospital Marqués de Valdecilla
Santander
- Recruiting
Hospital Provincial de Toledo
Toledo
- Withdrawn
Hospital Clínico Universitario de Valencia
Valencia
- Withdrawn
Hospital Universitari i Politècnic La Fe
Valencia
- Recruiting
Hospital de Vic
Vic
- Recruiting
Hospital Álvaro Cunqueiro
Vigo
- Withdrawn
Hospital Provincial de Zamora
Zamora
Italy18 sites, 18 recruiting
- Recruiting
Ospedali Riuniti di Ancona
Ancona
- Recruiting
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari
- Recruiting
Ospedale Versilia di Camaiore
Camaiore
- Not yet recruiting
Cura Neuropsichiatria Villa Von Siebenthal
Genzano di Roma
- Recruiting
P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
Giulianova
- Recruiting
Mental Health Department (MDSM) ASP di Messina
Messina
- Recruiting
Ospedale Niguarda
Milan
- Recruiting
Dipartimento di Salute Mentale -ASL Modena
Modena
- Recruiting
Centro Salute Mentale di Pesaro
Pesaro
- Recruiting
Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
Roma
- Not yet recruiting
Fondazione PTV Policlinico Tor Vergara
Roma
- Recruiting
Villa Maria Dia Hospital
Rome
- Recruiting
Unit Mental Health District Nº72- ASL Salerno
Salerno
- Recruiting
Unita Operativa- Salute Mentale di Salerno
Salerno
- Recruiting
Centro di Salute Mentale
Saluzzo
- Recruiting
Ospedale Madonna del Soccorso San Bendedetto del Tronto
San Benedetto del Tronto
- Recruiting
Dipartimento di Salute Mentale- ASL Napoli
San Giorgio a Cremano
- Recruiting
ASL di Teramo
Teramo
France16 sites, 6 recruiting
- Withdrawn
H. Paul-Guiraud Clamart
Clamart
- Withdrawn
CH Jonzac
Jonzac
- Withdrawn
Centre Psychotherapique Nancy
Laxou
- Withdrawn
Centre Hospitalier Esquirol
Limoges
- Recruiting
CHS-La Colombière
Montpellier
- Withdrawn
CHU Nantes Hospital Saint Jacques
Nantes
- Withdrawn
CH Sainte Marie
Nice
- Recruiting
CHU Pasteur
Nice
- Recruiting
Hospital Maison Blanche XX Bichat
Paris
- Withdrawn
Hospital Sainte Anne
Paris
- Recruiting
Centre Hospitalier Henri laborit
Poitiers
- Recruiting
Centre Hospitalier Gillaume regnier-CHGR
Rennes
- Withdrawn
Centre Hospitalier Alpes Isere
Saint-Égrève
- Recruiting
CHU-Saint Etienne
Saint-Etienne
- Withdrawn
CHITS - Hôpital Chalucet
Toulon
- Withdrawn
CHS St. Remy
Vesoul
Germany6 sites
- Withdrawn
Rheinhessen-Fachklinik Alzey
Alzey
- Withdrawn
Vivantes Klinikum
Berlin
- Withdrawn
LVR- Klinikum Düsseldorf
Düsseldorf
- Withdrawn
Universitätsklinikum des Saarlandes
Homburg
- Withdrawn
Universitätsklinikum Magdeburg
Magdeburg
- Withdrawn
Kbo-Isar-Ampere-Klinikum Taufkirchen
Taufkirchen
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Keywords
- adherence, long-acting injectable antipsychotic, all-cause treatment discontinuation, recent-onset schizophrenia, daily oral atypical antipsychotic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: First 12 months after initiation of maintenance treatment
Secondary outcomes (7)
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
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.
Measured: First 12 months after initiation of maintenance treatment
Relapse rate (%) in the 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.
Measured: First 12 months after initiation of maintenance treatment
Change over time in CGI-S (score)
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.
Measured: From index date up to a maximun of 12 months
Change over time in QLS-5 (score)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From index date up to a maximun of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start13 Jul 2017
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Europe Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Medical Department, Study director, Otsuka Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130465
- Sponsor's protocol ID
- 031-303-00136
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34592798
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
- ClinicalTrials.gov ID
- NCT03130465
- Acronym / sponsor ID
- 031-303-00136
- Conditions
- Schizophrenia
- Keywords
- adherence, long-acting injectable antipsychotic, all-cause treatment discontinuation, recent-onset schizophrenia, daily oral atypical antipsychotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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.*
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Time frame: 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
Change over time in CGI-S (score)
Time frame: 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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 34592798Such 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Department study director
Otsuka Europe
67 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Otsuka Pharmaceutical Europe Ltd at 67 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Spain, Italy, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang-Silvanto, PhD (+44 (0) 2037475000, jwang-silvanto@otsuka-europe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP (time frame: First 12 months after initiation of maintenance treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.