(Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies) and Relation to Depression and Anxiety in SLE
February 5, 2024 updated by: Heba Maher Kamaly, Sohag University
(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
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).
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Osama S Daif Allah, Assistant Professor
- Phone Number: 01006425746
- Email: hebamaher1919@gmail.com
Study Contact Backup
- Name: Heba M Kamaly, Assistant lecture
- Phone Number: 01093128552
- Email: hebamaher1919@gmail.com
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag faculty of medicine
-
Contact:
- Osama S Daif Allah, Assistant Professor
- Phone Number: 01006425746
- Email: hebamaher1919@gmail.com
-
Contact:
- Heba M Kamaly, Assistant lecture
- Phone Number: 01093128552
- Email: hebamaher1919@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- - Any patient with any autoimmune disease other than systemic lupus erythematosus.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: case
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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the degree of depression
Time Frame: 1 year
|
by using zung self-rating depression scale
|
1 year
|
|
the degree of anxiety
Time Frame: 1 year
|
by using zung self-rating anxiety scale
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anti-Ribosomal P Protein antibody
Time Frame: 1 year
|
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
|
|
Anti-U1 RNP antibody
Time Frame: 1 year
|
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
|
|
Anti-Nucleosome antibody
Time Frame: 1 year
|
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
|
|
Anti-Double Strad DNA Antibody
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 14, 2024
Primary Completion (Estimated)
December 14, 2024
Study Completion (Estimated)
February 14, 2025
Study Registration Dates
First Submitted
February 5, 2024
First Submitted That Met QC Criteria
February 5, 2024
First Posted (Estimated)
February 13, 2024
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-01-07MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.