Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

Mood Disorders Clinical Trial

— EMOTION  

Official title:

Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817072
• Other study ID #: P/2019/462
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Charline Vauchy, PhD
• Phone: +333 81 21 88 75
• Email: cvauchy[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients (=18 ; = 80)
• Patient with rheumatoid arthritis (RA) according to the ACR 2010 criteria, axial or peripheral spondyloarthritis (SpA) according to ASAS criteria, ankylosing spondylitis (AS) according to the New York criteria or psoriatic arthritis (PsA) according to CASPAR criteria
• Signature of informed consent
• Affiliation to a French social security or receiving such a scheme

Exclusion Criteria:

• Patient having previously received anti-TNFa treatment
• Patient with previously diagnosed depressive or psychiatric pathology and / or receiving anti-depressant treatment
• Subjects with limited legal capacity.
• Subjects judged by the investigator to be unlikely to comply with study procedures
• Subjects with no social security coverage.
• Pregnant women.
• Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.

Related Conditions & MeSH terms

• Collagen Diseases
• Mood Disorders
• Rheumatic Diseases

Intervention

Other:
• Blood sample
Blood sample (20mL) for pro-inflammatory cytokines assay

Locations

Country	Name	City	State
France	University Hospital	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of depressive symptoms	Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms	1 month after initiation of anti-TNFa therapy
Secondary	Evaluation of disease activity	Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease)	3 months after initiation of anti-TNFa therapy
Secondary	Evaluation of disease activity	Evaluation with DAS28 (Disease Activity Score 28-joint count) (minimum value: 0; maximum value: 9.4; increases with the activity of the disease)	3 months after initiation of anti-TNFa therapy
Secondary	Evaluation of disease activity	Evaluation with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (minimum value: 0 (no disease activity); maximum value: 10 (very active disease))	3 months after initiation of anti-TNFa therapy
Secondary	Evaluation of disease activity	Evaluation with ASDAS (Ankylosing Spondylitis Disease Activity Score) (minimum value: 0 (no disease activity); value >3.5 between : very high disease activity)	3 months after initiation of anti-TNFa therapy
Secondary	Evaluation of Fatigue	Evaluation with Functional Assessment of Chronic Illness Therapy	3 months after initiation of anti-TNFa therapy
Secondary	Evaluation of Pleasure	Evaluation with Snaith-Hamilton pleasure scale (minimum value: 0 (no disease activity); maximum value: 14 (very active disease)). A higher total SHAPS score indicated higher levels of anhedonia.	3 months after initiation of anti-TNFa therapy