Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants

NCT ID: NCT02485483

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1292 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

VADERA I

RA participants without a concurrent history of depression and who have not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) will be asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 \[12 ± 2 weeks\]) with a 10-14 week interval between assessments.

No interventions assigned to this group

VADERA II

All RA participants who are able to complete the PHQ-9 and BDI-II questionnaires, and have been scheduled for a RA consultation at one of the participating clinics will be eligible for participation.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Berlin, , Germany

Dresden, , Germany

Erlangen, , Germany

Erlangen, , Germany

Frankfurt, , Germany

Leipzig, , Germany

München, , Germany

Osnabrück, , Germany

Rostock, , Germany

Würzburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31136632 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27482854 (View on PubMed)

Other Identifiers

ML29326

Identifier Type: -

Identifier Source: org_study_id