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

NCT ID: NCT03005769

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Europe Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Department

Role: STUDY_DIRECTOR

Otsuka Europe

Locations

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Centro Salute Mentale

Ancona, , Italy

Site Status

SPDC ASST Spedali Civili

Brescia, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, , Italy

Site Status

Policlinico "G. Rodolico"

Catania, , Italy

Site Status

Policlinico Mater Domini

Catanzaro, , Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

Casa Di Cura Neuropsichiatrica Villa Von Siebenthal

Genzano di Roma, , Italy

Site Status

Ospedale Maria S.S. dello splendore

Giulianova, , Italy

Site Status

ASL Lecce

Lecce, , Italy

Site Status

ASST Grande Ospedale Metropolitano

Milan, , Italy

Site Status

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Milan, , Italy

Site Status

Ospedale San Gerardo

Monza, , Italy

Site Status

SCDU Psichiatria. AOU San Luigi Gonzaga

Orbassano, , Italy

Site Status

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status

Clinica Psichiatrica. Università di Palermo

Palermo, , Italy

Site Status

Università degli Studi di Perugia

Perugia, , Italy

Site Status

Centro di Salute Mentale

Pomezia, , Italy

Site Status

ASL Salerno

Pontecagnano, , Italy

Site Status

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Site Status

Azienda ULSS 9 Treviso

Treviso, , Italy

Site Status

Countries

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Italy

Other Identifiers

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031-306-00108

Identifier Type: -

Identifier Source: org_study_id

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