Unipolar DepressionCUDOSNCT01360307
Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale
An observational study of Unipolar Depression, run by AstraZeneca at 17 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- How many people
- 330 participants
- Where
- 17 sitesSpain
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Research Site
A Coruña
Research Site
Barcelona
Research Site
Cadiz
Research Site
Córdoba
Research Site
El Vendrell
Research Site
Granada
Research Site
Huelva
Research Site
Lugo
Research Site
Madrid
Research Site
Majadahonda
Research Site
Málaga
Research Site
Nigrán
Research Site
Palma Mallorca
Research Site
Salamanca
Research Site
Terrassa
Research Site
Tudela
Research Site
Vigo
About this study
Official title: Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder
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.
- Conditions
- Unipolar Depression
- Keywords
- psychometric validation, major depressive disorder, patient-reported outcome
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Useful Depression Outcome Scale
To analyze feasibility and reliability (internal consistency - Cronbach´s alpha) of the Spanish version of the scale
Measured: up to 12 weeks after a diagnoses of a major depressive disorder
Secondary outcomes (5)
Hamilton Depression Rating Scale
To analyze convergent validity of the Spanish version of the CUDOS scale
Measured: up to 12 weeks after a diagnoses of a major depressive disorder
SF 36
To analyze correlation in quality of life -item 18 of the CUDOS scale
Measured: up to 12 weeks after a diagnoses of a major depressive disorder
Patient Global Impression Scale
To analyze criterion validity of the Spanish version of the CUDOS scale
Measured: up to 12 weeks after a diagnoses of a major depressive disorder
Social Occupational Functioning Scale
To analyze correlation in functioning -item 17 of the CUDOS scale
Measured: up to 12 weeks after a diagnoses of a major depressive disorder
Clinically Global Impression Scale
To analyze criterion validity of the Spanish version of the CUDOS scale
Measured: up to 12 weeks after a diagnoses of a major depressive disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360307
- Sponsor's protocol ID
- NIS-NES-XXX-2011/1
- Acronym
- CUDOS
- Status last verified
- Dec 2011
- First submitted
- 16 May 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01360307
- Acronym / sponsor ID
- CUDOS / NIS-NES-XXX-2011/1
- Conditions
- Unipolar Depression
- Keywords
- psychometric validation, major depressive disorder, patient-reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically Useful Depression Outcome Scale
Time frame: 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
5 secondary outcomes
Hamilton Depression Rating Scale
Time frame: up to 12 weeks after a diagnoses of a major depressive disorder
SF 36
Time frame: up to 12 weeks after a diagnoses of a major depressive disorder
Patient Global Impression Scale
Time frame: up to 12 weeks after a diagnoses of a major depressive disorder
Social Occupational Functioning Scale
Time frame: up to 12 weeks after a diagnoses of a major depressive disorder
Clinically Global Impression Scale
Time frame: up to 12 weeks after a diagnoses of a major depressive disorder
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unipolar Depression, run by AstraZeneca at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Useful Depression Outcome Scale (time frame: up to 12 weeks after a diagnoses of a major depressive disorder). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.