SchizophreniaDOMINONCT03005769
Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy
An observational study of Schizophrenia, run by Otsuka Pharmaceutical Europe Ltd at 20 sites in Italy.
Trial summary
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 262 participants
- Where
- 20 sitesItaly
- Study dates
- Dec 2016to Jul 2017
- 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 initiated aripiprazole once-monthly treatment as per normal clinical practice at least 6 months before data collection.
Who may be able to join
- Adult patients (age ≥ 18 years at the time of aripiprazole once-monthly initiation)
- Male or female
- Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5), available at start of aripiprazole once-monthly treatment, and confirmed by the current investigator
- Aripiprazole once-monthly initiation (at least 1 injection) according to the clinical practice, at least 6 months before the inclusion and on June 1st 2015 or at a later date (index date)
- Aripiprazole once-monthly was the main antipsychotic at the time of treatment initiation
- Willingness to participate in the study; subjects must give their written consent to participate
Who cannot join
- The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
- Participation in a clinical trial during the retrospective follow-up period.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Centro Salute Mentale
Ancona
SPDC ASST Spedali Civili
Brescia
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari
Policlinico "G. Rodolico"
Catania
Policlinico Mater Domini
Catanzaro
Azienda Ospedaliero-Universitaria Careggi
Florence
Casa Di Cura Neuropsichiatrica Villa Von Siebenthal
Genzano di Roma
Ospedale Maria S.S. dello splendore
Giulianova
ASL Lecce
Lecce
ASST Grande Ospedale Metropolitano
Milan
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan
Ospedale San Gerardo
Monza
SCDU Psichiatria. AOU San Luigi Gonzaga
Orbassano
Azienda Ospedaliera di Padova
Padova
Clinica Psichiatrica. Università di Palermo
Palermo
Università degli Studi di Perugia
Perugia
Centro di Salute Mentale
Pomezia
ASL Salerno
Pontecagnano
Azienda Ospedaliera Universitaria Senese
Siena
Azienda ULSS 9 Treviso
Treviso
About this study
Official title: Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical predictors of persistence with this treatment.
Data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (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
- persistence, long-acting injectable antipsychotic, adherence
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence (number of days) with aripiprazole once-monthly treatment
Measured: During the first 6 months after aripiprazole once-monthly initiation.
Secondary outcomes (5)
Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.
Measured: Through study completion, at least 6 months.
Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)
Measured: Through study completion, at least 6 months.
Mean Clinical Global Impressions - Severity scale (CGI-S) changes
Measured: Through study completion, at least 6 months.
Characterization of the schizophrenia dimensions of the participating subjects according to the Lifetime Dimensions for Psychosis Scale (LDPS) questionnaire.
Measured: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
Characterization of the psychotic spectrum of the participating subjects according to Structured Clinical Interview for the Psychotic Spectrum (SCI-PSY) questionnaire.
Measured: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 262 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
- NCT03005769
- Sponsor's protocol ID
- 031-306-00108
- Acronym
- DOMINO
- Status last verified
- May 2017
- First submitted
- 21 Dec 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study
- ClinicalTrials.gov ID
- NCT03005769
- Acronym / sponsor ID
- DOMINO / 031-306-00108
- Conditions
- Schizophrenia
- Keywords
- persistence, long-acting injectable antipsychotic, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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 with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical predictors of persistence with this treatment.
Data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (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 initiated aripiprazole once-monthly treatment as per normal clinical practice at least 6 months before data collection.
Key inclusion criteria (6 listed)
- Adult patients (age ≥ 18 years at the time of aripiprazole once-monthly initiation)
- Male or female
- Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5), available at start of aripiprazole once-monthly treatment, and confirmed by the current investigator
- Aripiprazole once-monthly initiation (at least 1 injection) according to the clinical practice, at least 6 months before the inclusion and on June 1st 2015 or at a later date (index date)
- Aripiprazole once-monthly was the main antipsychotic at the time of treatment initiation
Key exclusion criteria (2 listed)
- The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
- Participation in a 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 (number of days) with aripiprazole once-monthly treatment
Time frame: During the first 6 months after aripiprazole once-monthly initiation.
5 secondary outcomes
Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.
Time frame: Through study completion, at least 6 months.
Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)
Time frame: Through study completion, at least 6 months.
Mean Clinical Global Impressions - Severity scale (CGI-S) changes
Time frame: Through study completion, at least 6 months.
Characterization of the schizophrenia dimensions of the participating subjects according to the Lifetime Dimensions for Psychosis Scale (LDPS) questionnaire.
Time frame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
Characterization of the psychotic spectrum of the participating subjects according to Structured Clinical Interview for the Psychotic Spectrum (SCI-PSY) questionnaire.
Time frame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
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 19 Jul 2017.
- 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
20 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 20 sites in Italy.
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 2 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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 (number of days) with aripiprazole once-monthly treatment (time frame: During the first 6 months after aripiprazole once-monthly initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2017.