Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

Launched by MAX-PLANCK-INSTITUTE OF PSYCHIATRY · Jun 6, 2025

Keywords

ClinConnect Summary

The AddVNS study is looking at a new treatment called transcutaneous auricular vagus nerve stimulation (tVNS) for people with depression, including those with bipolar disorder. Unlike traditional vagus nerve stimulation, which requires surgery, tVNS is a non-invasive method that is still being tested. The main goal of this study is to understand how tVNS works and to find out which factors might help predict how well patients respond to this treatment. To do this, researchers will assess various aspects of health and behavior in 86 participants over a period of 6 weeks.

To take part in this study, participants need to be between 18 and 65 years old and diagnosed with a depressive episode or bipolar disorder. They should be able to provide informed consent and must use a safe method of contraception if they are of childbearing age. Those with certain medical conditions, such as severe neurological diseases or active implants, won’t be eligible. Participants will either receive tVNS or a sham treatment (which is like a placebo) and will be closely monitored throughout the study. This research aims to gather important information that could improve future treatments for depression.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age 18-65 years, legally competent and able to provide informed consent;
• • 2. diagnosis of a depressive episode (MDD or bipolar disorder) according to DSM 4/DSM 5 or ICD-10/ICD-11;
• • 3. signed informed consent documents for the AddVNS study;
• • 4. signed informed consent and participation in the biobanking project of MPIP;
• • 5. use of a safe contraceptive method
• Exclusion Criteria:
• • 1. age \< 18 years or age \> 65 years;
• • 2. pregnancy or planning to get pregnant during the study period, breastfeeding;
• • 3. legal supervision;
• • 4. pervasive developmental disorders and/or intellectual disability;
• • 5. acute substance abuse (e.g., alcohol, prescription or illicit drugs);
• • 6. severe neurological disease;
• • 7. technically or anatomically not possible tVNS (e.g., microtia or anotia, vagotomy);
• • 8. current treatment with an established neurostimulation method (e.g., ECT, rTMS, VNS);
• • 9. metallic foreign bodies, implanted intracranial devices or cerebral shunts;
• • 10. severe general illness (e.g., relevant anemia requiring transfusion, high-grade cardiac arrythmia, severe cardiomyopathy);
• • 11. active implants (e.g., cochlear implant, cardiac pacemaker, implantable cardioverter-defibrillator)