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

July 28, 2021 updated by: Friedemann Paul, Charite University, Berlin, Germany

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory - II
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Investigators

  • Principal Investigator: Friedemann Paul, Prof. Dr., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENIM (Other Identifier: Amphera)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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