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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UNKNOWN
50 participants
OBSERVATIONAL
2019-08-01
2023-06-30
Brief Summary
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Detailed Description
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The aim of this sub-project is to analyze the time-course of biological correlates of treatment resistant major depression as well as neurobiological markers of treatment response to treatment with DBS in a well-characterized patient population during 12 month of DBS.
Specific neurobiological analyses include testing of
1. epigenetic markers (DNA methylation in candidate genes of depression and epigenome-wide association studies, EWAS)
2. markers of neuroinflammation (cytokines, neuropeptides and other immune factors)
3. micro RNAs and transcriptome signatures
4. markers of neurodegeneration (neurofilament light protein)
5. metabolomic analyses and
6. endocrinological parameters including glucose tolerance.
All markers will be tested in blood samples (and urine samples for metaboloic profiling) before neurosurgery as well as at several time points during DBS and sham condition intervals.
Additionally hemodynamic parameters will be analysed at test stimulation of the slMFB during neurosurgery.
The results will be correlated with clinical and other biological response parameters of the FORESEE III study and are hypothesized to indicate treatment response as well as allowing prediction of response to DBS. All neurobiological analyses will be linked in a tightly integrated and comprehensive translational approach.
Further, a volunteer group of healthy controls will be recruited and tested for blood-markers of neurodegeneration (neurofilament light protein, 4.) as well as metabolomic analyses in blood and urine (5.).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DBS patients
Patients with treatment resistant major depression participating in the FORESEE III study.
No interventions assigned to this group
Healthy controls
Age- and sex-matched healthy controls undergoing analyses of neurodegenerative markers (neurofilament light protein) in blood and metabolomic analyses in blood and urine.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* All healthy volunteers without any clinically significant psychiatric or somatic symptoms are eligible.
Exclusion Criteria
* Somatic diseases like diabetes, cancer and severe liver- and kidney-diseases
Healthy Controls:
* Any clinically significant psychiatric symptoms
* Conditions like diabetes, cancer or severe liver- and kidney diseases
* Drug or alcohol abuse
20 Years
75 Years
ALL
Yes
Sponsors
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German Center for Neurodegenerative Diseases (DZNE)
OTHER
University Medical Center Freiburg
OTHER
University Hospital, Bonn
OTHER
University of Freiburg
OTHER
University Hospital Freiburg
OTHER
Responsible Party
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Thomas E. Schlaepfer, Prof. Dr.
Professor Dr. Thomas E. Schläpfer
Principal Investigators
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Thomas E. Schläpfer, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Freiburg
Locations
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University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Susanne Spanier
Role: primary
Thomas E. Schläpfer, Prof. Dr.
Role: backup
References
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Spanier S, Kilian HM, Meyer DM, Schlaepfer TE. Treatment resistance in major depression is correlated with increased plasma levels of neurofilament light protein reflecting axonal damage. Med Hypotheses. 2019 Jun;127:159-161. doi: 10.1016/j.mehy.2019.03.022. Epub 2019 Mar 23.
Other Identifiers
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40418
Identifier Type: -
Identifier Source: org_study_id