Depression and Immune Function in Multiple Sclerosis (MS)
NCT ID: NCT02740296
Last Updated: 2021-07-29
Study Results
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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COMPLETED
104 participants
OBSERVATIONAL
2015-11-30
2017-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy controls
Healthy controls
No intervention
RRMS
Relapsing-Remitting Multiple Sclerosis
No intervention
RRMS+MDD
Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder
No intervention
MDD
Major Depressive Disorder
No intervention
Interventions
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No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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National Multiple Sclerosis Society
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
NeuroCure Clinical Research Center, Charite, Berlin
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Friedemann Paul
Prof. Dr.
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
Countries
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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.
Related Links
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Related Info
Other Identifiers
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DENIM
Identifier Type: -
Identifier Source: org_study_id
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