Trial document
DRKS00003231
Trial Description
Title
Validation of standardized questionnaires for depression
(WHO-5, PHQ-9, BDI-II) for rheumatoid arthritis and
study of the frequency of depression in RA
Trial Acronym
VADERA
URL of the Trial
[---]*
Brief Summary in Lay Language
Rheumatoid arthritis (RA) is a chronic disease, associated with a higher incidence of depression.
Information on depressive disease vary between 10 and 45%, depending on the measurement method.
So far there is no measuring instrument (questionnaire), which has been tested for this disease in patients with RA. The aim of this epidemiological study is to validate such a questionnaire. Subsequently, the validated questionnaire will be used to examine the actual incidence of depression in German RA patients.
The project consists of two parts.
In the first phase, VADERA I, standardized questionnaires for depression are tested in patients with RA.
VADERA II determines the frequency of depression in patients with RA.
In addition, disease activity, concomitant diseases and medication-classes are documented to detect possible correlations.
Brief Summary in Scientific Language
The project consists of two parts with different questions and objectives.
The first phase VADERA I will validate a suitable measuring instrument (questionnaire) for the detection of depression in RA. It is crucial to exclude the somatic component of the underlying disease and comorbidities from the answers. Therefore, the PHQ-9, the BDI-II, and the WHO-5 have been selected as standardized patient self-assessment questionnaires. They are proven in other diseases to minimize or nearly exclude the somatic effects. The results of these self-assessment questionnaires are set in relation to a standardized patient interview (MADRS).
Hypothetically, there is an influence of depression on the scores for the assessment of disease activity (DAS28, CDAI, SDAI). This impact will be measurable, if in parallel scores for active depression will be documented and a correlation can be established.
The second phase VADERA II checks the frequency of depression in RA and for the first time results will be obtained in a representative group of patients. At the same time by the documentation of disease activity, comorbidities and co-medication classes, possible corelations can be established.
Organizational Data
- DRKS00003231
- 2011/08/15
- [---]*
- no
- Approved
- 4431, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
Secondary IDs
- [---]*
Health Condition or Problem studied
- M05 - Seropositive rheumatoid arthritis
- M06.0 - Seronegative rheumatoid arthritis
Interventions/Observational Groups
- Part I: Survey of patients with rheumatoid arthritis using a questionnaire for depression. Part II: analysis of incidence of depression in RA patients with validated questionnaires
Characteristics
- Non-interventional
- Epidemiological study
- Other
- Open (masking not used)
- [---]*
- Other
- Screening
- Other
- N/A
- N/A
Primary Outcome
Part I: Validation of a depression score (WHO-5 = Well-Being-Index of the world health organisation, PHQ-9 - = Patient Health Questionnaire Depression with 9 questions, BDI-II = Beck's depression inventar) for rheumatoid arthritis
Secondary Outcome
Part II: Measure incidence of depression in rheumatoid arthritis with a validated instrument
Countries of Recruitment
- Germany
Locations of Recruitment
- Doctor's Practice
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Doctor's Practice
- Medical Center
- Doctor's Practice
Recruitment
- Actual
- 2012/01/13
- 1300
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
Additional Inclusion Criteria
confirmed rheumatoid arthritis
Exclusion Criteria
confirmed depression, secondary pain syndrome (fibromyalgy) in the second part of the study
Addresses
-
start of 1:1-Block address primary-sponsor
- Roche Pharma AG
- Emil-Barell-Str. 1
- 79639 Grenzach-Wyhlen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Roche Pharma AG
- Ms. Bettina Gauger
- Emil-Barell-Strasse 1
- 79639 Grenzach-Wyhlen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0671 92894727
- 0671 92894729
- bettina.gauger at roche.com
- http://www.roche.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Roche Pharma AG
- Ms. Dr. Heike Berthold
- Emil-Barell-Str. 1
- 79639 Grenzach-Wyhlen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 07624-142974
- 07624-6859
- heike.berthold at roche.com
- http://www.roche.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Roche Pharma AG
- Emil-Barell-Str. 1
- 79639 Grenzach-Wyhlen
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.roche.de
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Chugai Pharma Marketing LTD
- Lyoner Str. 15
- 60528 Frankfurt/Main
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact otherSupport
Status
- Recruiting complete, follow-up complete
- 2015/07/31