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Completed

NCT Number: NCT02740296

Depression and Immune Function in Multiple Sclerosis (MS)

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depressive Disorder Depressive Disorder, Major Immune System Diseases Mental Disorders Mood Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Age 18-55.
  • On stable treatment regime, either untreated or on disease modifying therapy (DMT) for > 6 months

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Beck Depression Inventory - II

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • National Multiple Sclerosis Society
  • NeuroCure Clinical Research Center, Charite, Berlin
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Acronym: DENIM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2016
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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