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OpenTrials
Completed

NCT Number: NCT01360307

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

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.

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Key information

Conditions

Unipolar Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinically Useful Depression Outcome Scale

    Time frame: 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 outcomes

  1. Hamilton Depression Rating Scale

    Time frame: up to 12 weeks after a diagnoses of a major depressive disorder

    To analyze convergent validity of the Spanish version of the CUDOS scale

  2. SF 36

    Time frame: 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

  3. Patient Global Impression Scale

    Time frame: up to 12 weeks after a diagnoses of a major depressive disorder

    To analyze criterion validity of the Spanish version of the CUDOS scale

  4. Social Occupational Functioning Scale

    Time frame: up to 12 weeks after a diagnoses of a major depressive disorder

    To analyze correlation in functioning -item 17 of the CUDOS scale

  5. Clinically Global Impression Scale

    Time frame: up to 12 weeks after a diagnoses of a major depressive disorder

    To analyze criterion validity of the Spanish version of the CUDOS scale

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: CUDOS

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 25, 2011
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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