(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

Intervention / Treatment

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

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag faculty of medicine
        • Contact:
        • Contact:

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:

  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.

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)
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

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

Sohag University

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

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

Keywords

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.

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