Depression and Anxiety in Rheumatoid Arthritis

Depression Clinical Trial

— DEAR  

Official title:

Depression and Anxiety in Rheumatoid Arthritis: Prevalence and Relation With Disease Activity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02122406
• Other study ID #: 31748\2009 progetto lorhen
• Status: Active, not recruiting
• Phase: N/A
• First received: April 22, 2014
• Last updated: December 4, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >18 years

• diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria

• being able to compile questionnaire

• current treatment with biological disease-modifying antirheumatic drug

Exclusion Criteria:

• Current treatment for anxiety or depressive disorder

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Arthritis
• Arthritis, Rheumatoid
• Depression
• Depressive Disorder
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Italy	IRCCS policlinico San Matteo - Reparto di Reumatologia	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score 28	Disease Activity Score base on 28 joint count	1 day of enrollement	No
Primary	Hospital Anxiety and Depression Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) questionnaire	1 day of enrollement	No