Actively Recruiting
Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
Led by Max-Planck-Institute of Psychiatry · Updated on 2025-06-15
86
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Invasive vagus nerve stimulation (VNS) is an approved treatment of treatment-resistant depression (TRD) in Europe and in USA. Because of the associated possible surgical complications as well as side effects, invasive VNS is applied limitedly in the treatment of depression. Transcutaneous auricular VNS (tVNS), on the other hand, is a non-invasive alternative to traditional invasive VNS. tVNS is still considered an experimental treatment for depression. This is due to the limited high-quality evidence from randomized clinical studies, the not yet fully understood biological mechanisms of action, along with overall limited knowledge about the optimal stimulation parameters. To address these issues, the AddVNS study was initiated. The AddVNS study intends to recruit n=86 patients of the Max Planck Institute of Psychiatry with depression. The patients participating in the AddVNS study are going to receive either tVNS or sham tVNS for a period of 6 weeks. The primary objective of the study is to identify biological, psychological, socio-economic, and clinical biomarkers associated with treatment progression and response to treatment in patients with depression undergoing tVNS. To achieve this, an exploratory design with an assessment of many different parameters including psychophysiology, imaging, blood-based multi-omics, microbiome, psychometrics and neuropsychology will be used.
CONDITIONS
Official Title
Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, legally competent and able to provide informed consent
- Diagnosis of a depressive episode (major depressive disorder or bipolar disorder) according to DSM or ICD criteria
- Signed informed consent for participation in the AddVNS study
- Signed informed consent and participation in the biobanking project of the Max Planck Institute of Psychiatry
- Use of a safe contraceptive method
You will not qualify if you...
- Age below 18 years or above 65 years
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Under legal supervision
- Pervasive developmental disorders or intellectual disability
- Acute substance abuse such as alcohol or drugs
- Severe neurological disease
- Technical or anatomical inability to receive tVNS (e.g., ear malformations, prior vagotomy)
- Current treatment with established neurostimulation methods (e.g., ECT, rTMS, invasive VNS)
- Presence of metallic foreign bodies, implanted intracranial devices, or cerebral shunts
- Severe general illnesses (e.g., anemia requiring transfusion, serious cardiac conditions)
- Active implants like cochlear implants, cardiac pacemakers, or defibrillators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Max Planck Institute of Psychiatry
Munich, Germany, 80804
Actively Recruiting
Research Team
E
Evangelos Kokolakis, MD
CONTACT
I
Iven-Alex von Mücke-Heim, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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