Depression and Immune Function in Multiple Sclerosis (MS)

NCT ID: NCT02740296

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Multiple Sclerosis Depressive Disorder, Major

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy controls

Healthy controls

No intervention

Intervention Type OTHER

RRMS

Relapsing-Remitting Multiple Sclerosis

No intervention

Intervention Type OTHER

RRMS+MDD

Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder

No intervention

Intervention Type OTHER

MDD

Major Depressive Disorder

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

NeuroCure Clinical Research Center, Charite, Berlin

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Friedemann Paul

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Friedemann Paul, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 22316314 (View on PubMed)

Related Links

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Other Identifiers

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DENIM

Identifier Type: -

Identifier Source: org_study_id

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