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临床试验/NCT02740296
NCT02740296已完成不适用

Depression and Immune Function in Multiple Sclerosis (MS)

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Beck Depression Inventory - II

研究概览

简要总结

Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more frequently in MS than in other chronic diseases including other neurological and inflammatory disorders and may contribute to lower quality of life, cognitive problems, difficulties at work, and poorer long term health outcomes. Despite its clinical relevance, the biological mechanisms which may be responsible for the high risk for MS patients to develop depression are unknown.

In this observational study, investigators explore the molecular mechanisms responsible for the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with depression. Investigators will compare the molecular and phenotypical profile of immune cells obtained from RRMS patients with clinical depression (n=50), matched MS patients who do not suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients with depression but without a comorbid neurological disorder (n=50).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Relapsing remitting MS by McDonald Criteria (for RRMS and RRMS+MDD groups).
  • Currently meeting diagnostic criteria for Major Depressive Disorder (for MDD and RRMS+MDD groups)
  • On stable treatment regime, either untreated or on disease modifying therapy (DMT) for > 6 months

排除标准

  • Secondary-progressive or primary progressive MS.
  • Substance abuse for more than 6 months.
  • Pregnancy
  • Use of steroids or vaccination or infections in the previous 3 months.
  • Signs of serious psychiatric pathology other than depression including schizophrenia, bipolar disorder or developmental and learning disorders including disorders on the autism spectrum
  • Antidepressant medication.

结局指标

主要结局

Beck Depression Inventory - II

时间窗: 14 days

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

Friedemann Paul

Prof. Dr.

Charite University, Berlin, Germany

研究点 (1)

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