Depression and Immune Function in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— DENIM  

Official title:

Depression and Immune Function in Multiple Sclerosis (MS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740296
• Other study ID #: DENIM
• Status: Completed
• Start date: November 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	National Multiple Sclerosis Society, NeuroCure Clinical Research Center, Charite, Berlin, Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Dörr J, Ohlraun S, Skarabis H, Paul F. Efficacy of vitamin D supplementation in multiple sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial. Trials. 2012 Feb 8;13:15. doi: 10.1186/1745-6215-13-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory - II		14 days

External Links

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