NCT07022171Recruiting
Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
Physiological and Molecular Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 9 May 2025
- Start date
- 18 Mar 2025
- Primary completion date
- 17 Mar 2030
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Diseases
- Bipolar disorder
- NCT number
- NCT07022171
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 18 Mar 2025 to the primary completion date, 17 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- acute substance abuse (e.g., alcohol, prescription or illicit drugs);
- current treatment with an established neurostimulation method (e.g., ECT, rTMS, VNS);
Other illness
- pervasive developmental disorders and/or intellectual disability;
- severe neurological disease;
- severe general illness (e.g., relevant anemia requiring transfusion, high-grade cardiac arrythmia, severe cardiomyopathy);
- active implants (e.g., cochlear implant, cardiac pacemaker, implantable cardioverter-defibrillator)
Age
- age \< 18 years or age \> 65 years;
Other
- pregnancy or planning to get pregnant during the study period, breastfeeding;
- legal supervision;
- technically or anatomically not possible tVNS (e.g., microtia or anotia, vagotomy);
- metallic foreign bodies, implanted intracranial devices or cerebral shunts;
Who the study is looking for
- age 18-65 years, legally competent and able to provide informed consent;
- diagnosis of a depressive episode (MDD or bipolar disorder) according to DSM 4/DSM 5 or ICD-10/ICD-11;
- signed informed consent documents for the AddVNS study;
- signed informed consent and participation in the biobanking project of MPIP;
- use of a safe contraceptive method
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Max-Planck-Institute of Psychiatry Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.