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NCT Number: NCT03005769

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

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).

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Salute Mentale, Ancona, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Persistence (number of days) with aripiprazole once-monthly treatment

    Time frame: During the first 6 months after aripiprazole once-monthly initiation.

Secondary outcomes

  1. Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.

    Time frame: Through study completion, at least 6 months.

  2. Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)

    Time frame: Through study completion, at least 6 months.

  3. Mean Clinical Global Impressions - Severity scale (CGI-S) changes

    Time frame: Through study completion, at least 6 months.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Europe Ltd

Industry

Registry information

Official study title

Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study

Acronym: DOMINO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2016
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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