The Pathogenesis of Depression - Possible Autoimmune Mechanisms

NCT05293899 | Recruiting

• 1 other identifier: 143-19EMC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

exome sequencing approach DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Mental co-morbidity.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek medical center

Afula, 1910500, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood samples will be collected for genetic investigation. We will collect 10 ml of whole blood in EDTA tubes. The tubes will be refrigerated in 4-degree Celsius and will be delivered to the genetics laboratory in Ha Emek Medical Center. DNA will be then extracted from the samples and will be stored in the refrigerator. Genetics Laboratory, under the responsibility of Dr. Morad Khayat, the lab manager. After completion of the first phase proteome analysis, a further investigation into which genetic variants are most susceptible and those will be then analyzed. The information for each participant will be confidential for each patient and coded as noted. 2. The genetic material will be kept for 10 years in the Genetic lab, for further investigation. Participants who will decide not to continue with the testing - their specimens will be destroyed. 3. In any case of finding a known genetic aberration, the participants will be referred to genetic counseling.

MeSH Terms

Conditions

Depression; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: February 15, 2022
• Primary Completion: February 15, 2026
• Study Completion: April 15, 2026
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

IL (1)