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Clinical Trials/NCT05293899
NCT05293899
Recruiting
Not Applicable

The Pathogenesis of Depression - Possible Autoimmune Mechanisms

HaEmek Medical Center, Israel1 site in 1 country200 target enrollmentFebruary 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
HaEmek Medical Center, Israel
Enrollment
200
Locations
1
Primary Endpoint
1. Find genetic association or genetic basis to depression associated with autoimmune diseases
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2022
End Date
April 15, 2026
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Einat Mader

M.D

HaEmek Medical Center, Israel

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 1 day

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

Study Sites (1)

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