Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale

Completed

• Conditions: Unipolar Depression

• Registration Number: NCT01360307
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Study Start: 2011-06
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically Useful Depression Outcome Scale	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

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	up to 12 weeks after a diagnoses of a major depressive disorder	To analyze convergent validity of the Spanish version of the CUDOS scale
SF 36	up to 12 weeks after a diagnoses of a major depressive disorder	To analyze correlation in quality of life -item 18 of the CUDOS scale
Patient Global Impression Scale	up to 12 weeks after a diagnoses of a major depressive disorder	To analyze criterion validity of the Spanish version of the CUDOS scale
Social Occupational Functioning Scale	up to 12 weeks after a diagnoses of a major depressive disorder	To analyze correlation in functioning -item 17 of the CUDOS scale
Clinically Global Impression Scale	up to 12 weeks after a diagnoses of a major depressive disorder	To analyze criterion validity of the Spanish version of the CUDOS scale

Trial Locations

Locations (1)

Research Site; 🇪🇸 Vigo, Spain