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

NCT06255743 | Recruiting

• 1 other identifier: Soh-Med-24-01-07MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Systemic Lupus Erythematosus

Keywords

Depression -Anxiety-Anti-Ribosomal P Protein Antibody - Anti-U1 Antibody - Anti-Nucleosome Antibody - Anti-Double Strad DNA Antibody

Outcome Measures

Primary Outcomes (2)

• the degree of depression

  by using zung self-rating depression scale

  1 year

• the degree of anxiety

  by using zung self-rating anxiety scale

  1 year

Secondary Outcomes (4)

• Anti-Ribosomal P Protein antibody

  1 year

• Anti-U1 RNP antibody

  1 year

• Anti-Nucleosome antibody

  1 year

• Anti-Double Strad DNA Antibody

  1 year

Study Arms (1)

case

EXPERIMENTAL

cases diagnosed systemic lupus erythematosus we measure degree of depression and anxiety and relation to (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies)

Diagnostic Test: Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies

Interventions

Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies DIAGNOSTIC_TEST

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

case

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

RECRUITING

Related 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.

  PMID: 10643702 BACKGROUND

• 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.

  PMID: 15593352 BACKGROUND

• 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.

  PMID: 21158976 BACKGROUND

• 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.

  PMID: 21198385 BACKGROUND

• 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.

  PMID: 19121871 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Osama S Daif Allah, Assistant Professor

CONTACT

01006425746; hebamaher1919@gmail.com

Heba M Kamaly, Assistant lecture

CONTACT

01093128552; hebamaher1919@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture at rhematology and rehabilitation department at sohag university

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 14, 2024
• Primary Completion: December 14, 2024
• Study Completion: February 14, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)