Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy
- Conditions
- Schizophrenia
- Registration Number
- NCT03005769
- Lead Sponsor
- Otsuka Pharmaceutical Europe Ltd
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 262
- 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
- The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
- Participation in a clinical trial during the retrospective follow-up period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Persistence (number of days) with aripiprazole once-monthly treatment During the first 6 months after aripiprazole once-monthly initiation.
- Secondary Outcome Measures
Name Time Method Mean Clinical Global Impressions - Severity scale (CGI-S) changes Through study completion, at least 6 months. 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 Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs) Through study completion, at least 6 months. Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons. 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
Trial Locations
- 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
🇮🇹Firenze, 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
🇮🇹Milano, Italy
Scroll for more (10 remaining)Centro Salute Mentale🇮🇹Ancona, Italy