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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02485483

ML29326

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,292 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,292 participants in 2 patient groups

VADERA I

Description:

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.

VADERA II

Description:

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.