SchizophreniaPROSIGONCT03130478
Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole in Spain
An observational study of Schizophrenia, run by Otsuka Pharmaceutical Europe Ltd at 15 sites in Spain.
Trial summary
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 119 participants
- Where
- 15 sitesSpain
- Study dates
- 18 Jul 2017to 30 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will include adult patients with schizophrenia who have been initiated with AOM as primary maintenance AP treatment during an inpatient stay due to an acute schizophrenia relapse in a real clinical practice setting at least 6 months before the inclusion in the study (regardless of the current treatment at inclusion). Since persistence is part of the primary objective of the study, patients who discontinued the maintenance treatment with AOM before the inclusion period of the study should also be included.
Who may be able to join
- Adult patients (age ≥ 18 years at the time of AOM initiation).
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders V available at start of AOM treatment, and confirmed by the current investigator.
- Having been hospitalized for an acute psychotic relapse and having been initiated with AOM as primary maintenance antipsychotic treatment, in accordance with the terms of the marketing authorisation, during the hospitalisation, at least 6 months before the inclusion and before November 1st 2016 (and up to January 2016 at the earliest).
- Provision of patient informed consent unless a) not required by local regulations, b) it would take a non-reasonable effort* or c) if 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 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 at time of AOM initiation.
- Patients who receive, after AOM initiation, a concomitant oral antipsychotic treatment for more than 4 weeks (with the exception of low dose quetiapine)*
- Low dose quetiapine is acceptable up to a maximum of 150 mg daily only for sedative purposes, but not for the induction of any psychopharmacological effect on mood and/or psychosis.
- Participation in an interventional clinical trial during the retrospective follow-up period.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Universitario de Álava
Alava
Hospital Fundación Alcorcón
Alcorcón
Numància Salut Mental (Parc Sanitari St Joan de Deu)
Barcelona
Hospital de Ciudad Real
Ciudad Real
Hospital IAS Girona
Girona
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat
Complejo Asistencial Universitario de Leon
León
Fundación Jiménez Díaz
Madrid
HGU Gregorio Marañón
Madrid
Hospital Infanta Leonor
Madrid
Hospital Carlos Haya
Málaga
Parc Sanitari St. Joan de Deu (St. Boi)
Sant Boi de Llobregat
Hospital Santiago de Compostela
Santiago de Compostela
Hospital Universitario Virgen del Rocío
Seville
Hospital Álvaro Cunqueiro
Vigo
About this study
Official title: Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole Long-acting Injection in the Spanish Clinical Practice: a Retrospective, Observational Study
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Read the detailed description
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Data from each patient will be collected after informed consent is obtained (if possible), and will include retrospective information mainly from the index date (start of AOM treatment, baseline timepoint) until the last information available in the patient file at the time of data collection (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once-monthly).
- Conditions
- Schizophrenia
- Keywords
- long-acting injectable antipsychotic, persistence
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence (days) with aripiprazole once-monthly
To describe in real-world practice the impact of demographic and clinical characteristics on persistence in patients with schizophrenia initiated on aripiprazole once-monthly (AOM) during an inpatient stay due to an acute schizophrenia relapse.
Measured: First 6 months after treatment initiation
Secondary outcomes (7)
Description of reasons of treatment discontinuation (number of discontinuations per reason)
Date of AOM interruption or discontinuation and reason for discontinuation
Measured: From treatment initiation up to patient inclusion (minimum 6 months)
Change over time in Clinical Global Impressions - Severity (CGI-S) scale
Clinical Global Impressions - Severity (CGI-S) scale at index date (if available in patient's file or estimated by the investigator according to medical records) and CGI-S up to patient's inclusion (if available in patients' file or estimated by the investigator according to medical records). CGI-S up to patient's inclusion (if available in patients' file or estimated by the investigator according to medical records).
Measured: From treatment initiation up to patient inclusion (minimum 6 months)
Change over time in the Brief Psychiatric Rating Scale (BPRS)
Brief Psychiatric Rating Scale (BPRS) at index date (if available in patient's file) and BPRS up to the patient's inclusion (if available in patients' file).
Measured: From treatment initiation up to patient inclusion (minimum 6 months)
Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings)
Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings)
Measured: From treatment initiation up to patient inclusion (minimum 6 months)
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Measured: From treatment initiation up to patient inclusion (minimum 6 months)
Description of non-pharmacological interventions aiming to improve functionality (types, numbers of patients per type)
Description of non-pharmacological interventions aiming to improve functionality (including, if applicable, initiation and end dates of Institutional support, Cognitive behavioural therapy (CBT), Assertive Community Treatment/Case management, Group or individual psychoeducation, Family psychoeducation, Group or individual psychotherapy, Structured rehabilitation program, Occupational support, Severe mental illness management program)
Measured: From treatment initiation up to patient inclusion (minimum 6 months)
Description of patterns of alcohol and drug abuse and/or dependence (patterns of drug abuse, type of substance, frequency of consumption)
To qualitatively describe patterns of drug abuse and/or dependence
Measured: From treatment initiation up to patient inclusion (minimum 6 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 start18 Jul 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
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
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Europe Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Department, Study director, Otsuka Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130478
- Sponsor's protocol ID
- 031-307-00162
- Acronym
- PROSIGO
- Status last verified
- Aug 2018
- First submitted
- 21 Apr 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olivares JM, Gonzalez-Pinto A, Paramo M; PROSIGO Study Group. Predictors of persistence in patients with schizophrenia treated with aripiprazole once-monthly long-acting injection in the Spanish clinical practice: a retrospective, observational study. Eur Psychiatry. 2021 Apr 12;64(1):e40. doi: 10.1192/j.eurpsy.2021.23.
PubMed 33840396
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole Long-acting Injection in the Spanish Clinical Practice: a Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT03130478
- Acronym / sponsor ID
- PROSIGO / 031-307-00162
- Conditions
- Schizophrenia
- Keywords
- long-acting injectable antipsychotic, persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- 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, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Detailed description
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Data from each patient will be collected after informed consent is obtained (if possible), and will include retrospective information mainly from the index date (start of AOM treatment, baseline timepoint) until the last information available in the patient file at the time of data collection (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once-monthly).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will include adult patients with schizophrenia who have been initiated with AOM as primary maintenance AP treatment during an inpatient stay due to an acute schizophrenia relapse in a real clinical practice setting at least 6 months before the inclusion in the study (regardless of the current treatment at inclusion). Since persistence is part of the primary objective of the study, patients who discontinued the maintenance treatment with AOM before the inclusion period of the study should also be included.
Key inclusion criteria (6 listed)
- Adult patients (age ≥ 18 years at the time of AOM initiation).
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders V available at start of AOM treatment, and confirmed by the current investigator.
- Having been hospitalized for an acute psychotic relapse and having been initiated with AOM as primary maintenance antipsychotic treatment, in accordance with the terms of the marketing authorisation, during the hospitalisation, at least 6 months before the inclusion and before November 1st 2016 (and up to January 2016 at the earliest).
- Provision of patient informed consent unless a) not required by local regulations, b) it would take a non-reasonable effort* or c) if the source patient is deceased or untraceable.
- If allowable by 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 (5 listed)
- The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
- Chronically hospitalized patients at time of AOM initiation.
- Patients who receive, after AOM initiation, a concomitant oral antipsychotic treatment for more than 4 weeks (with the exception of low dose quetiapine)*
- Participation in an interventional clinical trial during the retrospective follow-up period.
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
Persistence (days) with aripiprazole once-monthly
Time frame: First 6 months after treatment initiation
To describe in real-world practice the impact of demographic and clinical characteristics on persistence in patients with schizophrenia initiated on aripiprazole once-monthly (AOM) during an inpatient stay due to an acute schizophrenia relapse.
7 secondary outcomes
Description of reasons of treatment discontinuation (number of discontinuations per reason)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Change over time in Clinical Global Impressions - Severity (CGI-S) scale
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Change over time in the Brief Psychiatric Rating Scale (BPRS)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of non-pharmacological interventions aiming to improve functionality (types, numbers of patients per type)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of patterns of alcohol and drug abuse and/or dependence (patterns of drug abuse, type of substance, frequency of consumption)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Derived from this study: PubMed 33840396Olivares JM, Gonzalez-Pinto A, Paramo M; PROSIGO Study Group. Predictors of persistence in patients with schizophrenia treated with aripiprazole once-monthly long-acting injection in the Spanish clinical practice: a retrospective, observational study. Eur Psychiatry. 2021 Apr 12;64(1):e40. doi: 10.1192/j.eurpsy.2021.23.
- 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
15 sites in 1 country: 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 15 sites in Spain.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence (days) with aripiprazole once-monthly (time frame: First 6 months after treatment initiation). 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 NCT03130478, 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 21 Aug 2018.