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临床试验/NCT01376492
NCT01376492已完成不适用

Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain

Janssen-Cilag, S.A.0 个研究点目标入组 709 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
709

研究概览

简要总结

The purpose of this study is to establish the relationship between performance of patients with schizophrenia and relationship with perceived quality of sleep. The secondary objectives are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to assess the potential epidemiological risk factors associated with the perceived impairment of quality of sleep; to establish the relationship between the clinical condition and the quality of sleep perceived; to assess the performance level of patients.

详细描述

This is a multicenter, cross-sectional, epidemiological study in the daily clinical practice on the relationship between personal and social functionality and quality of sleep perceived in outpatients with schizophrenia. It is proposed to perform a simple screening for detecting schizophrenic patients reporting sleep disturbances. These patients will be assessed in a single visit and will be administered a number of quality of life and functional assessment scales. N/A

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

  • Patient diagnosed of schizophrenia
  • reporting sleep disturbances at the time of the visit or patient not reporting sleep disturbances at the time of the visit
  • who are on stable antipsychotic therapy for at least 6 months prior to inclusion in the study
  • (or guardian/ legal representative) consenting to participate in the study by signing the written informed consent.

排除标准

  • Patient who, in the investigator's opinion, fails to keep an adequate cognitive ability to continue the study and complete the questionnaires
  • who has any type of severe sleep disturbances related to disorders of the patient other than schizophrenia (e.g., nightmares, nocturnal fears, restless leg syndrome)
  • or included in another clinical study or trial that can interfere with the normal control of the disease.

研究者

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

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