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

NCT03005769 | Completed

• 1 other identifier: 031-306-00108
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 20

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).

Conditions

Schizophrenia

Keywords

persistence; long-acting injectable antipsychotic; adherence

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

• Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.

  Through study completion, at least 6 months.

• Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)

  Through study completion, at least 6 months.

• Mean Clinical Global Impressions - Severity scale (CGI-S) changes

  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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients will include adult patients with schizophrenia who initiated aripiprazole once-monthly treatment as per normal clinical practice at least 6 months before data collection.

You may qualify if:

• 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 was the main antipsychotic at the time of treatment initiation
• Willingness to participate in the study; subjects must give their written consent to participate

You may not qualify if:

• The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
• Participation in a clinical trial during the retrospective follow-up period.

Sponsors & Collaborators

• Otsuka Pharmaceutical Europe Ltd: lead

Study Sites (20)

Centro Salute Mentale

Ancona, Italy

Location

SPDC ASST Spedali Civili

Brescia, Italy

Location

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Italy

Location

Policlinico "G. Rodolico"

Catania, Italy

Location

Policlinico Mater Domini

Catanzaro, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Location

Casa Di Cura Neuropsichiatrica Villa Von Siebenthal

Genzano di Roma, Italy

Location

Ospedale Maria S.S. dello splendore

Giulianova, Italy

Location

ASL Lecce

Lecce, Italy

Location

ASST Grande Ospedale Metropolitano

Milan, Italy

Location

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Milan, Italy

Location

Ospedale San Gerardo

Monza, Italy

Location

SCDU Psichiatria. AOU San Luigi Gonzaga

Orbassano, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Clinica Psichiatrica. Università di Palermo

Palermo, Italy

Location

Università degli Studi di Perugia

Perugia, Italy

Location

Centro di Salute Mentale

Pomezia, Italy

Location

ASL Salerno

Pontecagnano, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Azienda ULSS 9 Treviso

Treviso, Italy

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Department

  Otsuka Europe

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)