Multiple Sclerosis Clinical Trial
— DENIMOfficial title:
Depression and Immune Function in Multiple Sclerosis (MS)
NCT number | NCT02740296 |
Other study ID # | DENIM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | June 2017 |
Verified date | July 2021 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 104 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | National Multiple Sclerosis Society, NeuroCure Clinical Research Center, Charite, Berlin, Universitätsklinikum Hamburg-Eppendorf |
Germany,
Dörr 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Beck Depression Inventory - II | 14 days |
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