NCT01360307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

May 16, 2011

Last Update Submit

December 5, 2011

Conditions

Keywords

psychometric validationmajor depressive disorderpatient-reported outcome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Hamilton Depression Rating Scale

    up to 12 weeks after a diagnoses of a major depressive disorder

  • SF 36

    up to 12 weeks after a diagnoses of a major depressive disorder

  • Patient Global Impression Scale

    up to 12 weeks after a diagnoses of a major depressive disorder

  • Social Occupational Functioning Scale

    up to 12 weeks after a diagnoses of a major depressive disorder

  • Clinically Global Impression Scale

    up to 12 weeks after a diagnoses of a major depressive disorder

Study Arms (1)

Major Depressive Disorder Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research Site

A Coruña, Spain

Location

Research Site

Barcelona, Spain

Location

Research Site

Cadiz, Spain

Location

Research Site

Córdoba, Spain

Location

Research Site

El Vendrell, Spain

Location

Research Site

Granada, Spain

Location

Research Site

Huelva, Spain

Location

Research Site

Lugo, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Majadahonda, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Nigrán, Spain

Location

Research Site

Palma Mallorca, Spain

Location

Research Site

Salamanca, Spain

Location

Research Site

Terrassa, Spain

Location

Research Site

Tudela, Spain

Location

Research Site

Vigo, Spain

Location

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 25, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations