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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01360307

Collaborator

(none)

330

Enrollment

Locations

Duration (Months)

19.4

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression

Study Design

Study Type:

Observational

Actual Enrollment :

330 participants

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Major Depressive Disorder Patients

Outcome Measures

Primary Outcome Measures

Clinically Useful Depression Outcome Scale [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 Outcome Measures

Hamilton Depression Rating Scale [up to 12 weeks after a diagnoses of a major depressive disorder]
To analyze convergent validity of the Spanish version of the CUDOS scale
SF 36 [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
Patient Global Impression Scale [up to 12 weeks after a diagnoses of a major depressive disorder]
To analyze criterion validity of the Spanish version of the CUDOS scale
Social Occupational Functioning Scale [up to 12 weeks after a diagnoses of a major depressive disorder]
To analyze correlation in functioning -item 17 of the CUDOS scale
Clinically Global Impression Scale [up to 12 weeks after a diagnoses of a major depressive disorder]
To analyze criterion validity of the Spanish version of the CUDOS scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Research Site	A Coruña	Spain
2	Research Site	Barcelona	Spain
3	Research Site	Cadiz	Spain
4	Research Site	Cordoba	Spain
5	Research Site	El Vendrell	Spain
6	Research Site	Granada	Spain
7	Research Site	Huelva	Spain
8	Research Site	Lugo	Spain
9	Research Site	Madrid	Spain
10	Research Site	Majadahonda	Spain
11	Research Site	Malaga	Spain
12	Research Site	Nigran	Spain
13	Research Site	Palma Mallorca	Spain
14	Research Site	Salamanca	Spain
15	Research Site	Terrasa	Spain
16	Research Site	Tudela	Spain
17	Research Site	Vigo	Spain