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

Unipolar Depression Clinical Trial

— CUDOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360307
• Other study ID #: NIS-NES-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: December 5, 2011
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Unipolar Depression

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hamilton Depression Rating Scale	To analyze convergent validity of the Spanish version of the CUDOS scale	up to 12 weeks after a diagnoses of a major depressive disorder	No
Secondary	SF 36	To analyze correlation in quality of life -item 18 of the CUDOS scale	up to 12 weeks after a diagnoses of a major depressive disorder	No
Secondary	Patient Global Impression Scale	To analyze criterion validity of the Spanish version of the CUDOS scale	up to 12 weeks after a diagnoses of a major depressive disorder	No
Secondary	Social Occupational Functioning Scale	To analyze correlation in functioning -item 17 of the CUDOS scale	up to 12 weeks after a diagnoses of a major depressive disorder	No
Secondary	Clinically Global Impression Scale	To analyze criterion validity of the Spanish version of the CUDOS scale	up to 12 weeks after a diagnoses of a major depressive disorder	No