Depression and Immune Function in Multiple Sclerosis (MS)

NCT02740296 | Completed

• 1 other identifier: DENIM
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Sclerosis; Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory - II

  14 days

Study Arms (4)

Healthy controls

Healthy controls

Other: No intervention

RRMS

Relapsing-Remitting Multiple Sclerosis

Other: No intervention

RRMS+MDD

Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder

Other: No intervention

MDD

Major Depressive Disorder

Other: No intervention

Interventions

No intervention OTHER

Healthy controls; MDD; RRMS; RRMS+MDD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited at neurological outpatient clinics and neurologcial clinics of the Charité and neurologists' medical practices.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• National Multiple Sclerosis Society: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• NeuroCure Clinical Research Center, Charite, Berlin: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• Dorr 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.

  PMID: 22316314 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Sclerosis; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Friedemann Paul, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

DE (1)