The Pathogenesis of Depression - Possible Autoimmune Mechanisms

NCT ID: NCT05293899

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2026-04-15

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.

Conditions

Depression; Autoimmune Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Einat Mader

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haemek medical center

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

gilat ron avraham

Role: primary

gilataavraham@gmail.com

0528495336

Other Identifiers

143-19EMC

Identifier Type: -

Identifier Source: org_study_id