DENIM: Depression and Immune Function in Multiple Sclerosis (MS)

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT02740296

Collaborator

National Multiple Sclerosis Society (Other), Universitätsklinikum Hamburg-Eppendorf (Other), NeuroCure Clinical Research Center, Charite, Berlin (Other)

104

Enrollment

Location

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Depressive Disorder, Major	Other: No intervention

Study Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Depression and Immune Function in Multiple Sclerosis (MS)

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Beck Depression Inventory - II [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.