Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 20
- 主要终点
- Persistence (number of days) with aripiprazole once-monthly treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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)
- •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
排除标准
- •The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
- •Participation in a clinical trial during the retrospective follow-up period.
结局指标
主要结局
Persistence (number of days) with aripiprazole once-monthly treatment
时间窗: During the first 6 months after aripiprazole once-monthly initiation.
次要结局
- 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)