The Pathogenesis of Depression - Possible Autoimmune Mechanisms

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05293899
Collaborator
(none)
200
1
49.9
4

Study Details

Study Description

Brief Summary

It has long been claimed that depression, and other psychiatric illness, might be a manifestation of immune dysregulation involving the Central nervous system. Depression is associated with a significantly increased risk of autoimmune disease compared to those without a history of depression. The increased risk of autoimmune diseases is during the first year following the onset of depression .Conversely, up to 50% of patients with autoimmune diseases show an impairment of health-related quality of life and exhibit depressive symptoms.

The aggregation of depression and some specific autoimmune diseases may demonstrate shared inherited pathogenesis.

The first phase of the study will include patients with the diagnosis of depression. The control group will consist of a healthy population, according to medical records and will be recruited through a recruitment ad and volunteers. In the second phase of the study first and second-degree relatives (parents, siblings, children, grandparents, aunts, uncles and cousins) who are diagnosed with autoimmune disease/s will be recruited. Auto-immune diseases will include - Rheumatoid Arthritis (RA), juvenile idiopathic arthritis JIA), Seronegative spondyloarthropathies (SPA) including inflammatory bowel disease (IBD), psoriatic arthritis (PsA), and ankylosing spondylitis. Other autoimmune diseases: Systemic Lupus Erythematosus, Sjogren' syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IIM), any Overlap of the above including mixed connective tissue disease (MCTD), systemic vasculitis (see Chapel Hill classification criteria). All autoimmune diseases will be confirmed by an expert rheumatologist or an internist. Celiac disease, Diabetes Mellitus type I, autoimmune thyroiditis, autoimmune hepatitis will be confirmed by a gastroenterologist, endocrinologist or an internist.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: exome sequencing approach

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Pathogenesis of Depression - Possible Autoimmune Mechanisms
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Feb 15, 2026
Anticipated Study Completion Date :
Apr 15, 2026

Outcome Measures

Primary Outcome Measures

  1. 1. Find genetic association or genetic basis to depression associated with autoimmune diseases [1 day]

    1. Find genetic association or genetic basis to depression associated with autoimmune diseases

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients must meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for a diagnosis of depression.

  • Sufficient knowledge of the Hebrew language

  • A stabled mental state. If hospitalized, patients are scheduled for discharge based on clinical assessment of psychiatric symptoms.

Exclusion Criteria:
  • Mental co-morbidity.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haemek medical center Afula Israel 1910500

Sponsors and Collaborators

  • HaEmek Medical Center, Israel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Einat Mader, M.D, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT05293899
Other Study ID Numbers:
  • 143-19EMC
First Posted:
Mar 24, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022