Non-invasive ear (auricular) vagus nerve stimulation for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AddVNS is a monocentric, randomized, double-blind, sham-controlled interventional study conducted at the Max Planck Institute of Psychiatry that plans to enroll 86 adult patients. Participants aged 18–65 with a current major depressive episode or bipolar depressive episode are randomized to either active transcutaneous auricular vagus nerve stimulation (tVNS) or sham stimulation for six weeks. The protocol combines clinical rating scales with biological sampling, neurophysiological measures, and biobanking to identify biomarkers and clarify mechanisms of action. The study also aims to explore optimal stimulation parameters and correlate physiological changes with clinical response.

Why it matters

Who can join: the full rules

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)

Where it's running

• Max Planck Institute of Psychiatry
  Munich, Germany Recruiting

Study contacts

• Principal investigator: Peter Falkai, MD — Max-Planck-Institute of Psychiatry
• Study coordinator: Evangelos Kokolakis, MD
• Email: ambulanz@psych.mpg.de
• Phone: 0049-89-30622-1000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.