Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy (DOMINO)

July 14, 2017 updated by: Otsuka Pharmaceutical Europe Ltd

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).

Study Overview

Status

Status

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

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.

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 (Actual)

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.
262

Contacts and Locations

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

Study Locations

  • Italy
      • Ancona, Italy
        • Centro Salute Mentale
      • Brescia, Italy
        • SPDC ASST Spedali Civili
      • Cagliari, Italy
        • Azienda Ospedaliero-Universitaria di Cagliari
      • Catania, Italy
        • Policlinico "G. Rodolico"
      • Catanzaro, Italy
        • Policlinico Mater Domini
      • Firenze, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Genzano di Roma, Italy
        • Casa Di Cura Neuropsichiatrica Villa Von Siebenthal
      • Giulianova, Italy
        • Ospedale Maria S.S. dello splendore
      • Lecce, Italy
        • Asl Lecce
      • Milano, Italy
        • Azienda Ospedaliera Fatebenefratelli e Oftalmico
      • Milano, Italy
        • ASST Grande Ospedale Metropolitano
      • Monza, Italy
        • Ospedale San Gerardo
      • Orbassano, Italy
        • SCDU Psichiatria. AOU San Luigi Gonzaga
      • Padova, Italy
        • Azienda Ospedaliera Di Padova
      • Palermo, Italy
        • Clinica Psichiatrica. Università di Palermo
      • Perugia, Italy
        • Università degli Studi di Perugia
      • Pomezia, Italy
        • Centro di Salute Mentale
      • Pontecagnano, Italy
        • Asl Salerno
      • Siena, Italy
        • Azienda Ospedaliera Universitaria Senese
      • Treviso, Italy
        • Azienda ULSS 9 Treviso

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. Adult patients (age ≥ 18 years at the time of aripiprazole once-monthly initiation)
  2. Male or female
  3. 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
  4. 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)
  5. Aripiprazole once-monthly was the main antipsychotic at the time of treatment initiation
  6. Willingness to participate in the study; subjects must give their written consent to participate

Exclusion Criteria:

  1. The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
  2. Participation in a clinical trial during the retrospective follow-up period.

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

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
Time Frame
Persistence (number of days) with aripiprazole once-monthly treatment
Time Frame: During the first 6 months after aripiprazole once-monthly initiation.
During the first 6 months after aripiprazole once-monthly initiation.

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
Time Frame
Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.
Time Frame: Through study completion, at least 6 months.
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.
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.
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
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
Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation

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

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.
December 1, 2016

Primary Completion (Actual)

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.
July 1, 2017

Study Completion (Actual)

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.
July 1, 2017

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).
December 21, 2016

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.
December 28, 2016

First Posted (Estimate)

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.
December 29, 2016

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.
July 19, 2017

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.
July 14, 2017

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.
May 1, 2017

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.
  • 031-306-00108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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