The Pathogenesis of Depression - Possible Autoimmune Mechanisms

Depression Clinical Trial

Official title:

The Pathogenesis of Depression - Possible Autoimmune Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293899
• Other study ID #: 143-19EMC
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: April 15, 2026

Study information

• Verified date: March 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 15, 2026
• Est. primary completion date: February 15, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Depression
• Depressive Disorder

Intervention

Diagnostic Test:
• exome sequencing approach
Depending on the primary results in the proteomic and the metabolic profiling, this pilot study will search for genetic associations, using an exome sequencing approach to individuals. The findings will be compared to individuals without depression, and to relatives of depressed patients who suffer from autoimmune diseases.

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Find genetic association or genetic basis to depression associated with autoimmune diseases	1. Find genetic association or genetic basis to depression associated with autoimmune diseases	1 day