Clinical trial NCT01360307: Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale
Official title: Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unipolar Depression
Keywords: psychometric validation
major depressive disorder
patient-reported outcome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.


Eligibility 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

Primary outcomes:
measure: Clinically Useful Depression Outcome Scale
timeFrame: up to 12 weeks after a diagnoses of a major depressive disorder
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: up to 12 weeks after a diagnoses of a major depressive disorder
measure: SF 36
timeFrame: up to 12 weeks after a diagnoses of a major depressive disorder
measure: Patient Global Impression Scale
timeFrame: up to 12 weeks after a diagnoses of a major depressive disorder
measure: Social Occupational Functioning Scale
timeFrame: up to 12 weeks after a diagnoses of a major depressive disorder
measure: Clinically Global Impression Scale
timeFrame: up to 12 weeks after a diagnoses of a major depressive disorder
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: El Vendrell
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Nigran
country: Spain
facility: Research Site
city: Palma Mallorca
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Terrasa
country: Spain
facility: Research Site
city: Tudela
country: Spain
facility: Research Site
city: Vigo
country: Spain
facility: Research Site
Study officials:
References: