跳至主要内容
临床试验/NCT00399334
NCT00399334已完成不适用

Study PROFILe3: Clinic Observations Profile of Relapse and Readmission in Emergency/Acute Settings: Epidemiologic Survey in Schizophrenic Patients

Janssen-Cilag, S.A.0 个研究点目标入组 1,607 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,607
主要终点
Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain

研究概览

简要总结

The purpose of this study is to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain.

详细描述

Long-term treatment in schizophrenia begins in acute hospitalization. However inadequate treatment options in non-compliant patients discharged from acute inpatient settings are often leading to recidivism and frequent re-hospitalization. The objective of this epidemiologic survey is to evaluate epidemiological characteristics of relapse and readmission in acute psychiatric units. If long-term treatment in schizophrenia begins in acute hospitalization the use of the new long-acting injectable antipsychotics after an acute psychotic episode as a standard maintenance medication could prevent relapse and readmissions. This is a pharmaco-epidemiological study, which collects structured safety data and it is carried out in Spain. All data collected will be cross-sectional or retrospective and will include the following: demographic data, diagnosis, psychiatric history and co-morbidities, hospitalization record (previous 3 years), treatment record and physician's opinion on patient's treatment compliance. The primary objectives are to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain, to determine the most important risk factors which predicts the number of hospital re-admissions and to identify the impact of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses. The second objective is to describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. as prescribed

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Schizophrenia or Schizoaffective disorder with a diagnosis over 2 years and that are hospitalized in a Short-Term Psychiatric Hospitalization Unit or Acute Unit

排除标准

  • Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
  • Patients with Schizophrenia or Schizoaffective disorder with a diagnosis less than 2 years

研究组 & 干预措施

001

干预措施: antipsychotic medications (Drug)

结局指标

主要结局

Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain

时间窗: All data is collected in just one visit (i.e. cross-sectional and retrospective data)

次要结局

  • Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient.(1 visit (cross-sectional study))

研究者

发起方
Janssen-Cilag, S.A.
申办方类型
Industry

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