Clinical trial NCT03005769: Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: persistence
long-acting injectable antipsychotic
adherence
Lead sponsor: Otsuka Pharmaceutical Europe Ltd
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Persistence (number of days) with aripiprazole once-monthly treatment
timeFrame: During the first 6 months after aripiprazole once-monthly initiation.
Secondary outcomes:
measure: Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.
timeFrame: Through study completion, at least 6 months.
measure: Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)
timeFrame: Through study completion, at least 6 months.
measure: Mean Clinical Global Impressions - Severity scale (CGI-S) changes
timeFrame: Through study completion, at least 6 months.
measure: Characterization of the schizophrenia dimensions of the participating subjects according to the Lifetime Dimensions for Psychosis Scale (LDPS) questionnaire.
timeFrame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
measure: Characterization of the psychotic spectrum of the participating subjects according to Structured Clinical Interview for the Psychotic Spectrum (SCI-PSY) questionnaire.
timeFrame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Centro Salute Mentale
city: Brescia
country: Italy
facility: SPDC ASST Spedali Civili
city: Cagliari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Cagliari
city: Catania
country: Italy
facility: Policlinico "G. Rodolico"
city: Catanzaro
country: Italy
facility: Policlinico Mater Domini
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Genzano di Roma
country: Italy
facility: Casa Di Cura Neuropsichiatrica Villa Von Siebenthal
city: Giulianova
country: Italy
facility: Ospedale Maria S.S. dello splendore
city: Lecce
country: Italy
facility: ASL Lecce
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano
city: Milano
country: Italy
facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Orbassano
country: Italy
facility: SCDU Psichiatria. AOU San Luigi Gonzaga
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Clinica Psichiatrica. Università di Palermo
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
city: Pomezia
country: Italy
facility: Centro di Salute Mentale
city: Pontecagnano
country: Italy
facility: ASL Salerno
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Treviso
country: Italy
facility: Azienda ULSS 9 Treviso
Study officials:
affiliation: Otsuka Europe
name: Medical Department
role: STUDY_DIRECTOR
References: