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

Completed

• 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

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-29
• Status Verified: 2017-05
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-14
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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 & 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

ASL Lecce; 🇮🇹 Lecce, Italy

Casa Di Cura Neuropsichiatrica Villa Von Siebenthal; 🇮🇹 Genzano di Roma, Italy

Ospedale Maria S.S. dello splendore; 🇮🇹 Giulianova, Italy

ASST Grande Ospedale Metropolitano; 🇮🇹 Milano, Italy

SCDU Psichiatria. AOU San Luigi Gonzaga; 🇮🇹 Orbassano, Italy

Azienda Ospedaliera Fatebenefratelli e Oftalmico; 🇮🇹 Milano, Italy

Ospedale San Gerardo; 🇮🇹 Monza, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Clinica Psichiatrica. Università di Palermo; 🇮🇹 Palermo, Italy

Università degli Studi di Perugia; 🇮🇹 Perugia, Italy

Centro di Salute Mentale; 🇮🇹 Pomezia, Italy

ASL Salerno; 🇮🇹 Pontecagnano, Italy

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy

Azienda ULSS 9 Treviso; 🇮🇹 Treviso, Italy