Neurobiological Analyses Within the FORESEE III Study

Status Recruiting

Clinical Trial Summary

In this observational, non-invasive clinical study different neurobiological analyses will be performed in a group of patients with severe treatment resistant major depression participating in an efficacy study of deep brain stimulation of the superolateral branch of the medial forebrain bundle (slMFB) - FORESEE III.

Clinical Trial Description

This study is a sub-project of the FORESEE III study (Controlled Randomized Clinical Trial to assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients with Treatment Resistant Major Depression). The FORESEE III study itself is a randomized, sham-controlled, double blind (patient and observer blinded) clinical trial to assess the antidepressant effect of DBS compared to sham. 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.). ;

Study Design

Related Conditions & MeSH terms

Depression
Depressive Disorder, Treatment-Resistant
Treatment Resistant Depression

Clinical Trial Details

NCT number	NCT04021823
Study type	Observational
Source	University Hospital Freiburg
Contact	Susanne Spanier
Phone	?+49 761 270 69800?
Email	susanne.spanier@uniklinik-freiburg.de
Status	Recruiting
Phase
Start date	August 1, 2019
Completion date	June 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.