Clinical trial NCT02485483: Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants
Official title: Validation of Standardized Questionnaires on Depression for Rheumatoid Arthritis (RA) (VADERA I) and Investigation of the Frequency of Depression in RA (VADERA II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2015-06-30
Enrollment: 1292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VADERA I was conducted in 9 clinical centers across Germany. VADERA II was conducted in 10 centers representing the spectrum of clinical settings in Germany where participants are diagnosed with rheumatoid arthritis and included large academic medical centers, community hospitals and private rheumatology practices across Germany.

Brief summary: The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3 months regarding their current emotional condition using standardized questionnaires. On the basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to assess the prevalence of depression with RA in approximately 1000 participants.

Detailed description: VADERA I is regarded as interventional epidemiologic study. The study was considered as interventional because of the use of the questionnaires and interview for the diagnosis of depression. VADERA II is a cross-sectional epidemiologic study.

Eligibility criteria: Inclusion Criteria:

* VADERA I: Participants diagnosed with RA, who did not suffer from a concurrent, manifest depressive disorder and had been scheduled for a RA consultation at one of the participating clinics
* VADERA II: All participants diagnosed with RA who were able to complete the questionnaires and had been scheduled for a RA consultation at one of the participating clinics

Primary outcomes:
measure: PHQ-9 Score at Baseline: VADERA I
timeFrame: Baseline
measure: PHQ-9 Score at Week 12 ± 2: VADERA I
timeFrame: Week 12 ± 2
measure: BDI-II Score at Baseline: VADERA I
timeFrame: Baseline
measure: BDI-II Score at Week 12 ± 2: VADERA I
timeFrame: Week 12 ± 2
measure: WHO-5 Index at Baseline: VADERA I
timeFrame: Baseline
measure: WHO-5 Index at Week 12 ± 2: VADERA I
timeFrame: Week 12 ± 2
measure: MADRS at Baseline: VADERA I
timeFrame: Baseline
measure: MADRS at Week 12 ± 2: VADERA I
timeFrame: Week 12 ± 2
measure: PHQ-9 Summary Score: VADERA II
timeFrame: Baseline
measure: BDI-II Summary Score: VADERA II
timeFrame: Baseline
measure: Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Erlangen
country: Germany
city: Frankfurt
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Osnabrück
country: Germany
city: Rostock
country: Germany
city: Würzburg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Englbrecht M, Alten R, Aringer M, Baerwald CG, Burkhardt H, Eby N, Flacke JP, Fliedner G, Henkemeier U, Hofmann MW, Kleinert S, Kneitz C, Kruger K, Pohl C, Schett G, Schmalzing M, Tausche AK, Tony HP, Wendler J. New insights into the prevalence of depressive symptoms and depression in rheumatoid arthritis - Implications from the prospective multicenter VADERA II study. PLoS One. 2019 May 28;14(5):e0217412. doi: 10.1371/journal.pone.0217412. eCollection 2019.
citation: Englbrecht M, Alten R, Aringer M, Baerwald CG, Burkhardt H, Eby N, Fliedner G, Gauger B, Henkemeier U, Hofmann MW, Kleinert S, Kneitz C, Krueger K, Pohl C, Roske AE, Schett G, Schmalzing M, Tausche AK, Peter Tony H, Wendler J. Validation of Standardized Questionnaires Evaluating Symptoms of Depression in Rheumatoid Arthritis Patients: Approaches to Screening for a Frequent Yet Underrated Challenge. Arthritis Care Res (Hoboken). 2017 Jan;69(1):58-66. doi: 10.1002/acr.23002.