Validation of Standardized Questionnaires on Depression for Rheumatoid Arthritis (RA) (VADERA I) and Investigation of the Frequency of Depression in RA (VADERA II)

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485483
• Other study ID #: ML29326
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: September 9, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul Ehrlich Institute
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to validate standardized questionnaires on depression for rheumatoid arthritis (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 standardised 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

VADERA I: Secured RA VADERA II: Secured RA, participant must be intellectually and linguistically able to independently answer the questionnaires

Exclusion Criteria:

VADERA I: Clear signs of depression

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Chugai Pharmaceutical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory II (BDI-II)		6 months	No
Primary	World Health Organization-5 Well-Being Index (WHO-5) Scores		6 months	No
Primary	Patient Health Questionnaire 9 (PHQ-9)		6 months	No
Secondary	VADERA II: Percentage of Participants With Depression		Baseline	No