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

Otsuka Pharmaceutical Europe Ltd262 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

262

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Centro Salute Mentale

Ancona, Italy

SPDC ASST Spedali Civili

Brescia, Italy

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Italy

Policlinico "G. Rodolico"

Catania, Italy

Policlinico Mater Domini

Catanzaro, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Casa Di Cura Neuropsichiatrica Villa Von Siebenthal

Genzano di Roma, Italy

Ospedale Maria S.S. dello splendore

Giulianova, Italy

ASL Lecce

Lecce, Italy

ASST Grande Ospedale Metropolitano

Milan, Italy

...and 10 more locations

Outcomes

Primary Outcomes

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

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

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