Multiple SclerosisDENIMNCT02740296
Depression and Immune Function in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis and Depressive Disorder, Major, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Depressive Disorder, Major
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited at neurological outpatient clinics and neurologcial clinics of the Charité and neurologists' medical practices.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Multiple Sclerosis, Depressive Disorder, Major
- Being tested
- No intervention
- Medical subject headings
- Multiple Sclerosis, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy controls Receives: Other: No intervention | |
| RRMS | Relapsing-Remitting Multiple Sclerosis Receives: Other: No intervention | |
| RRMS+MDD | Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder Receives: Other: No intervention | |
| MDD | Major Depressive Disorder Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory - II
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Universitätsklinikum Hamburg-Eppendorf, NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740296
- Sponsor's protocol ID
- DENIM
- Acronym
- DENIM
- Status last verified
- Jul 2021
- First submitted
- 12 Apr 2016
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22316314
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Immune Function in Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT02740296
- Acronym / sponsor ID
- DENIM / DENIM
- Conditions
- Multiple Sclerosis, Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Universitätsklinikum Hamburg-Eppendorf, NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: No interventionHealthy controls |
| RRMS | – | Other: No interventionRelapsing-Remitting Multiple Sclerosis |
| RRMS+MDD | – | Other: No interventionRelapsing-Remitting Multiple Sclerosis and Major Depressive Disorder |
| MDD | – | Other: No interventionMajor Depressive Disorder |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited at neurological outpatient clinics and neurologcial clinics of the Charité and neurologists' medical practices.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Healthy controls, MDD, RRMS, RRMS+MDD |
Primary outcome
Beck Depression Inventory - II
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 22316314Dorr 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedemann Paul, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Depressive Disorder, Major, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory - II (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.