Depression and Immune Function in Multiple Sclerosis (MS)

Completed

• Conditions: Multiple Sclerosis; Depressive Disorder, Major
• Interventions: Other: No intervention

• Registration Number: NCT02740296
• Lead Sponsor: Charite University, Berlin, Germany

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RRMS+MDD	No intervention	Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder
RRMS	No intervention	Relapsing-Remitting Multiple Sclerosis
MDD	No intervention	Major Depressive Disorder
Healthy controls	No intervention	Healthy controls

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory - II	14 days

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany