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

Charité University Medicine Berlin

Status: Completed

Conditions: Multiple Sclerosis; Depressive Disorder, Major

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02740296

DENIM

Details and patient eligibility

About

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).

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

104 participants in 4 patient groups

Healthy controls

Description:

Healthy controls

Treatment:

Other: No intervention

RRMS

Description:

Relapsing-Remitting Multiple Sclerosis

Treatment:

Other: No intervention

RRMS+MDD

Description:

Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder

Treatment:

Other: No intervention

MDD

Description:

Major Depressive Disorder

Treatment:

Other: No intervention