A Retrospective, Observational Study to Assess the Rate of Hospitalization in Patients With Schizophrenia Treated One Year Before With Oral Antipsychotics and One Year After With Long Acting Injectable Atypical Antipsychotics - REALAI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 主要终点
- Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use
研究概览
简要总结
The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics.
详细描述
This is a retrospective (take a look back at events that already have taken place), observational, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adults with a diagnosis of Schizophrenia during the time period from 01 January 2009 through 31-December-2013 (only for Mexican population). Data will be collected from clinical practice. The medical records of participants will be screened and eligible participants data will be collected. The period of observation will span from 12 months before initial Long Acting Injectable (LAI) use and in 12 months after the initial LAIs use. The rate of hospitalization will be primarily evaluated.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-Patients with the main diagnosis of schizophrenia with Diagnostic and Statistical Manual of Mental Disorders (DSM-4 criteria)
- •Only clinical records with complete information during the 2 years period selected for data analysis will be included
- •Participants treated with oral antipsychotics then switched to Long Acting Injectable (LAI) due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants choice, (Excluding for the Brazil population, when the switch has not been clearly justified or the switch has not been done during hospitalization)
- •Being regularly treated with LAI atypical antipsychotics for at least 1 year after the initial use of LAI atypical antipsychotics
排除标准
- •Participants with refractory schizophrenia (RS)
- •Participants that started LAI treatment as in-patients and patients that switched to LAI during hospitalization (only for Mexican population).
结局指标
主要结局
Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use
时间窗: 12 months before initial LAI use
Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported.
Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use
时间窗: 12 months after initial LAI use
次要结局
- Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia(approximately 2 years)
- Number of hospitalizations due to Psychotic Relapse of Schizophrenia(approximately 2 years)