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

Schizophrenia Clinical Trial

— DOMINO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005769
• Other study ID #: 031-306-00108
• Status: Completed
• Phase: N/A
• First received: December 21, 2016
• Last updated: July 14, 2017
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2017
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Italy	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	Azienda Ospedaliera Fatebenefratelli e Oftalmico	Milano
Italy	Ospedale San Gerardo	Monza
Italy	SCDU Psichiatria. AOU San Luigi Gonzaga	Orbassano
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

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence (number of days) with aripiprazole once-monthly treatment		During the first 6 months after aripiprazole once-monthly initiation.
Secondary	Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.		Through study completion, at least 6 months.
Secondary	Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)		Through study completion, at least 6 months.
Secondary	Mean Clinical Global Impressions - Severity scale (CGI-S) changes		Through study completion, at least 6 months.
Secondary	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
Secondary	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