(Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies) and Relation to Depression and Anxiety in SLE

Systemic Lupus Erythematosus Clinical Trial

Official title:

(Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies) Correlate With Depression and Anxiety in Systemic Lupus Erythematosus Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255743
• Other study ID #: Soh-Med-24-01-07MD
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: February 14, 2025

Study information

• Verified date: February 2024
• Source: Sohag University
• Contact: Osama S Daif Allah, Assistant Professor
• Phone: 01006425746
• Email: hebamaher1919[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study determine the relation between the degree of (Depression and Anxiety) in Systemic Lupus Erythematosus Patients by zung self rating depression scale and zung self rating anxiety scale and (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 14, 2025
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria or 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus.

2. Patients who is able to give informed consent to join the study.

Exclusion Criteria:

• - Any patient with any autoimmune disease other than systemic lupus erythematosus.

Related Conditions & MeSH terms

• Depression
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies
determine Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies) and its relation to the degree of Depression and Anxiety in Systemic Lupus Erythematosus Patients

Locations

Country	Name	City	State
Egypt	Sohag Faculty of Medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Amoura Z, Koutouzov S, Chabre H, Cacoub P, Amoura I, Musset L, Bach JF, Piette JC. Presence of antinucleosome autoantibodies in a restricted set of connective tissue diseases: antinucleosome antibodies of the IgG3 subclass are markers of renal pathogenicity in systemic lupus erythematosus. Arthritis Rheum. 2000 Jan;43(1):76-84. doi: 10.1002/1529-0131(200001)43:13.0.CO;2-I. — View Citation

Benito-Garcia E, Schur PH, Lahita R; American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines. Guidelines for immunologic laboratory testing in the rheumatic diseases: anti-Sm and anti-RNP antibody tests. Arthritis Rheum. 2004 Dec 15;51(6):1030-44. doi: 10.1002/art.20836. No abstract available. — View Citation

Diamond B, Bloom O, Al Abed Y, Kowal C, Huerta PT, Volpe BT. Moving towards a cure: blocking pathogenic antibodies in systemic lupus erythematosus. J Intern Med. 2011 Jan;269(1):36-44. doi: 10.1111/j.1365-2796.2010.02318.x. — View Citation

Gao HX, Campbell SR, Cui MH, Zong P, Hee-Hwang J, Gulinello M, Putterman C. Depression is an early disease manifestation in lupus-prone MRL/lpr mice. J Neuroimmunol. 2009 Feb 15;207(1-2):45-56. doi: 10.1016/j.jneuroim.2008.11.009. Epub 2009 Jan 3. — View Citation

Schattner E, Shahar G, Lerman S, Shakra MA. Depression in systemic lupus erythematosus: the key role of illness intrusiveness and concealment of symptoms. Psychiatry. 2010 Winter;73(4):329-40. doi: 10.1521/psyc.2010.73.4.329. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of depression	by using zung self-rating depression scale	1 year
Primary	the degree of anxiety	by using zung self-rating anxiety scale	1 year
Secondary	Anti-Ribosomal P Protein antibody	was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.	1 year
Secondary	Anti-U1 RNP antibody	was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.	1 year
Secondary	Anti-Nucleosome antibody	was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.	1 year
Secondary	Anti-Double Strad DNA Antibody	was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.	1 year