Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole Long-acting Injection in the Spanish Clinical Practice: a Retrospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 15
- 主要终点
- Persistence (days) with aripiprazole once-monthly
研究概览
简要总结
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
详细描述
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Data from each patient will be collected after informed consent is obtained (if possible), and will include retrospective information mainly from the index date (start of AOM treatment, baseline timepoint) until the last information available in the patient file at the time of data collection (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 AOM initiation).
- •Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders V available at start of AOM treatment, and confirmed by the current investigator.
- •Having been hospitalized for an acute psychotic relapse and having been initiated with AOM as primary maintenance antipsychotic treatment, in accordance with the terms of the marketing authorisation, during the hospitalisation, at least 6 months before the inclusion and before November 1st 2016 (and up to January 2016 at the earliest).
- •Provision of patient informed consent unless a) not required by local regulations, b) it would take a non-reasonable effort* or c) if the source patient is deceased or untraceable.
- •A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.
- •If allowable by Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.
排除标准
- •The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
- •Chronically hospitalized patients at time of AOM initiation.
- •Patients who receive, after AOM initiation, a concomitant oral antipsychotic treatment for more than 4 weeks (with the exception of low dose quetiapine)*
- •* Low dose quetiapine is acceptable up to a maximum of 150 mg daily only for sedative purposes, but not for the induction of any psychopharmacological effect on mood and/or psychosis.
- •Participation in an interventional clinical trial during the retrospective follow-up period.
结局指标
主要结局
Persistence (days) with aripiprazole once-monthly
时间窗: First 6 months after treatment initiation
To describe in real-world practice the impact of demographic and clinical characteristics on persistence in patients with schizophrenia initiated on aripiprazole once-monthly (AOM) during an inpatient stay due to an acute schizophrenia relapse.
次要结局
- Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings)(From treatment initiation up to patient inclusion (minimum 6 months))
- Change over time in the Brief Psychiatric Rating Scale (BPRS)(From treatment initiation up to patient inclusion (minimum 6 months))
- Description of non-pharmacological interventions aiming to improve functionality (types, numbers of patients per type)(From treatment initiation up to patient inclusion (minimum 6 months))
- Description of reasons of treatment discontinuation (number of discontinuations per reason)(From treatment initiation up to patient inclusion (minimum 6 months))
- Change over time in Clinical Global Impressions - Severity (CGI-S) scale(From treatment initiation up to patient inclusion (minimum 6 months))
- Description of patterns of alcohol and drug abuse and/or dependence (patterns of drug abuse, type of substance, frequency of consumption)(From treatment initiation up to patient inclusion (minimum 6 months))
- Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)(From treatment initiation up to patient inclusion (minimum 6 months))