N/A
Completed N=1,292
Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants
Source: ClinicalTrials.gov NCT02485483 ↗Enrolled (actual)
1,292
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: PHQ-9 Score at Baseline: VADERA I — 5.2 scores on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PHQ-9 Score at Baseline: VADERA I |
5.2 | <0.001 sig |
| PRIMARY PHQ-9 Score at Week 12 ± 2: VADERA I |
4.8 | 0.057 |
| PRIMARY BDI-II Score at Baseline: VADERA I |
9.3 | <0.001 sig |
| PRIMARY BDI-II Score at Week 12 ± 2: VADERA I |
8.5 | <0.001 sig |
| PRIMARY WHO-5 Index at Baseline: VADERA I |
61.1 | 0.034 sig |
| PRIMARY WHO-5 Index at Week 12 ± 2: VADERA I |
63.9 | 0.219 |
| PRIMARY MADRS at Baseline: VADERA I |
7.3 | — |
| PRIMARY MADRS at Week 12 ± 2: VADERA I |
6.8 | — |
| PRIMARY PHQ-9 Summary Score: VADERA II |
6.0 | — |
| PRIMARY BDI-II Summary Score: VADERA II |
10.1 | — |
| PRIMARY 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 |
55.1; 27.7; 55.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02485483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.