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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03005769

Acronym

DOMINO

Enrollment

262

Registered

2016-12-29

Start date

2016-12-31

Completion date

2017-07-31

Last updated

2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

persistence, long-acting injectable antipsychotic, adherence

Brief 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 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results