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New treatment option for Depressive Disorder
Official title Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
ClinicalTrials.gov ID: NCT07022171
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- age \ 65 years;
- pregnancy or planning to get pregnant during the study period, breastfeeding;
- legal supervision;
- pervasive developmental disorders and/or intellectual disability;
- acute substance abuse (e.g., alcohol, prescription or illicit drugs);
- severe neurological disease;
See the full eligibility criteria
- 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 \ 65 years;
- pregnancy or planning to get pregnant during the study period, breastfeeding;
- legal supervision;
- pervasive developmental disorders and/or intellectual disability;
- acute substance abuse (e.g., alcohol, prescription or illicit drugs);
- severe neurological disease;
- technically or anatomically not possible tVNS (e.g., microtia or anotia, vagotomy);
- current treatment with an established neurostimulation method (e.g., ECT, rTMS, VNS);
- metallic foreign bodies, implanted intracranial devices or cerebral shunts;
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.