Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale
CUDOS
Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder
1 other identifier
observational
330
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 6, 2011
December 1, 2011
5 months
May 16, 2011
December 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinically Useful Depression Outcome Scale
To analyze feasibility and reliability (internal consistency - Cronbach´s alpha) of the Spanish version of the scale
up to 12 weeks after a diagnoses of a major depressive disorder
Secondary Outcomes (5)
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
Study Arms (1)
Major Depressive Disorder Patients
Eligibility Criteria
Primary care clinic
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Cadiz, Spain
Research Site
Córdoba, Spain
Research Site
El Vendrell, Spain
Research Site
Granada, Spain
Research Site
Huelva, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Majadahonda, Spain
Research Site
Málaga, Spain
Research Site
Nigrán, Spain
Research Site
Palma Mallorca, Spain
Research Site
Salamanca, Spain
Research Site
Terrassa, Spain
Research Site
Tudela, Spain
Research Site
Vigo, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 25, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 6, 2011
Record last verified: 2011-12