跳至主要内容
临床试验/NCT01360307
NCT01360307已完成不适用

Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder

AstraZeneca1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2011年6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
AstraZeneca
入组人数
330
试验地点
1
主要终点
Clinically Useful Depression Outcome Scale

研究概览

简要总结

The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered instrument that not only evaluates depressive symptoms but also both functioning and quality of life. The assessment of patients´ perspective may provide valuable information that could be lost if relaying only on clinician evaluation. The purpose of this study is to achieve a psychometric validation into Spanish of the CUDOS scale in patients with major depression disorder in a primary care setting.

研究设计

研究类型
Observational
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

  • Major depression disorder diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria in the last 3 months
  • Major depression disorder diagnosis according to Prime-MD criteria in the last 3 months

排除标准

  • Be unable to understand and comply with the study requirements as judged by the investigator
  • Participation in another trial prior to enrolment into this study

结局指标

主要结局

Clinically Useful Depression Outcome Scale

时间窗: up to 12 weeks after a diagnoses of a major depressive disorder

To analyze feasibility and reliability (internal consistency - Cronbach´s alpha) of the Spanish version of the scale

次要结局

  • Hamilton Depression Rating Scale(up to 12 weeks after a diagnoses of a major depressive disorder)
  • SF 36(up to 12 weeks after a diagnoses of a major depressive disorder)
  • Patient Global Impression Scale(up to 12 weeks after a diagnoses of a major depressive disorder)
  • Social Occupational Functioning Scale(up to 12 weeks after a diagnoses of a major depressive disorder)
  • Clinically Global Impression Scale(up to 12 weeks after a diagnoses of a major depressive disorder)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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