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临床试验/NCT05293899
NCT05293899招募中不适用

The Pathogenesis of Depression - Possible Autoimmune Mechanisms

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
1. Find genetic association or genetic basis to depression associated with autoimmune diseases

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Mental co-morbidity.

结局指标

主要结局

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

时间窗: 1 day

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Einat Mader

M.D

HaEmek Medical Center, Israel

研究点 (1)

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