NCT07022171 Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
| NCT ID | NCT07022171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Max-Planck-Institute of Psychiatry |
| Condition | Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2030-03-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2025-03-18 with a primary completion date of 2030-03-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Peter Falkai, MD
PRINCIPAL INVESTIGATOR
Max-Planck-Institute of Psychiatry
Frequently Asked Questions
Who can join the NCT07022171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022171 currently recruiting?
Yes, NCT07022171 is actively recruiting participants. Contact the research team at ambulanz@psych.mpg.de for enrollment information.
Where is the NCT07022171 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT07022171 clinical trial?
NCT07022171 is sponsored by Max-Planck-Institute of Psychiatry. The principal investigator is Peter Falkai, MD at Max-Planck-Institute of Psychiatry. The trial plans to enroll 86 participants.