Trial document

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DRKS-ID: DRKS00003231

Trial Description

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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

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Trial Acronym

VADERA

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URL of the Trial

[---]*

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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.

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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.

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Organizational Data

DRKS-ID: DRKS00003231
Date of Registration in DRKS: 2011/08/15
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 4431, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg

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Secondary IDs

[---]*

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Health Condition or Problem studied

ICD10: M05 - Seropositive rheumatoid arthritis
ICD10: M06.0 - Seronegative rheumatoid arthritis

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Interventions/Observational Groups

Arm 1: 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

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Epidemiological study
Allocation: Other
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Screening
Assignment: Other
Phase: N/A
Off-label Drug use: N/A

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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

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Secondary Outcome

Part II: Measure incidence of depression in rheumatoid arthritis with a validated instrument

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Doctor's Practice Erlangen
Medical Center Universitätsklinikum Erlangen, Erlangen
Medical Center Schlossparkklinik, Berlin
Medical Center Universitätsklinik, Dresden
Medical Center Klinikum Südstadt Rostock, Rostock
Medical Center Universitätsklinik, Frankfurt a.M.
Medical Center Universitätsklinik, Leipzig
Doctor's Practice Osnabrück
Medical Center Universitätsklinik, Würzburg
Doctor's Practice München

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2012/01/13
Target Sample Size: 1300
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: no minimum age
Maximum Age: no maximum age

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Additional Inclusion Criteria

confirmed rheumatoid arthritis

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Exclusion Criteria

confirmed depression, secondary pain syndrome (fibromyalgy) in the second part of the study

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Addresses

Primary Sponsor
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- Roche Pharma AG
- Emil-Barell-Str. 1
- 79639 Grenzach-Wyhlen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Roche Pharma AG
- Ms. Bettina Gauger
- Emil-Barell-Strasse 1
- 79639 Grenzach-Wyhlen
- Germany
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- Telephone: 0671 92894727
- Fax: 0671 92894729
- E-mail: bettina.gauger at roche.com
- URL: http://www.roche.de
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Contact for Public Queries
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- Roche Pharma AG
- Ms. Dr. Heike Berthold
- Emil-Barell-Str. 1
- 79639 Grenzach-Wyhlen
- Germany
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- Telephone: 07624-142974
- Fax: 07624-6859
- E-mail: heike.berthold at roche.com
- URL: http://www.roche.de
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Roche Pharma AG
- Emil-Barell-Str. 1
- 79639 Grenzach-Wyhlen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.roche.de
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Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Chugai Pharma Marketing LTD
- Lyoner Str. 15
- 60528 Frankfurt/Main
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2015/07/31

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Trial Publications, Results and other Documents

Trial results: DGRh 2013, Poster RA26
Trial results: ACR 2013, Poster Nr. 2297

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* This entry means the parameter is not applicable or has not been set.