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

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: Completed
• Conditions: Schizophrenia

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.	Through study completion, at least 6 months.
Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)	Through study completion, at least 6 months.
Mean Clinical Global Impressions - Severity scale (CGI-S) changes	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.	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.	Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Europe Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: adherence; persistence; long-acting injectable antipsychotic
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 031-306-00108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO