Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT04817072
Status
Recruiting
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Conditions

  • Mood Disorders
  • Rheumatic Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Blood sample — OTHER
    Blood sample (20mL) for pro-inflammatory cytokines assay

Study Details

Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.

Key Dates

First listed
Mar 25, 2021
Start date
May 19, 2021
Status verified
Nov 2024
Primary completion
Nov 30, 2025
Completion
May 31, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Chronic inflammatory rheumatic disease
    Patients presenting a chronic inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), requiring anti-TNFa therapy and with a QIDS SR-16 (QIDS-SR 16-Quick Inventory of Depressive Symptomatology-Self Reported 16 items) score between 6 and 19

Primary Outcome Measure

Severity of depressive symptoms [ Time Frame: 1 month after initiation of anti-TNFa therapy ]

Central Contacts

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