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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01360307
First received: May 16, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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.


Condition
Unipolar Depression

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinically Useful Depression Outcome Scale [ Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder ] [ Designated as safety issue: No ]
    To analyze feasibility and reliability (internal consistency - Cronbach´s alpha) of the Spanish version of the scale


Secondary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder ] [ Designated as safety issue: No ]
    To analyze convergent validity of the Spanish version of the CUDOS scale

  • SF 36 [ Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder ] [ Designated as safety issue: No ]
    To analyze correlation in quality of life -item 18 of the CUDOS scale

  • Patient Global Impression Scale [ Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder ] [ Designated as safety issue: No ]
    To analyze criterion validity of the Spanish version of the CUDOS scale

  • Social Occupational Functioning Scale [ Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder ] [ Designated as safety issue: No ]
    To analyze correlation in functioning -item 17 of the CUDOS scale

  • Clinically Global Impression Scale [ Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder ] [ Designated as safety issue: No ]
    To analyze criterion validity of the Spanish version of the CUDOS scale


Enrollment: 330
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Major Depressive Disorder Patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360307

Locations
Spain
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Cadiz, Spain
Research Site
Cordoba, 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
Malaga, Spain
Research Site
Nigran, Spain
Research Site
Palma Mallorca, Spain
Research Site
Salamanca, Spain
Research Site
Terrasa, Spain
Research Site
Tudela, Spain
Research Site
Vigo, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01360307     History of Changes
Other Study ID Numbers: NIS-NES-XXX-2011/1
Study First Received: May 16, 2011
Last Updated: December 5, 2011
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ethics Committee

Keywords provided by AstraZeneca:
psychometric validation
major depressive disorder
patient-reported outcome

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014