Bipolar Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 to 65 years who are legally able to make their own decisions and give informed consent
- People who have been diagnosed with a depressive episode, either as part of major depressive disorder (MDD) or bipolar disorder, based on recognised diagnostic guidelines (DSM-4, DSM-5, ICD-10, or ICD-11)
- People who have signed the consent documents specific to the AddVNS study
- People who have signed consent to participate in a separate biological sample storage project run by MPIP (a research institute)
- People who are using a reliable method of contraception during the study
Who may not be able to join:
- People under 18 or over 65 years of age
- People who are pregnant, planning to become pregnant during the study, or currently breastfeeding
- People who are under legal supervision or guardianship
- People with pervasive developmental disorders (such as autism spectrum disorder) or an intellectual disability
- People currently experiencing acute substance misuse, such as alcohol, prescription medications used improperly, or illicit drugs
- People with a severe neurological disease
- People for whom the ear-based nerve stimulation device cannot be safely or physically applied — for example, due to absent or severely underdeveloped outer ears, or a previous surgical cutting of the vagus nerve (confirm with trial site)
- People currently receiving another established brain or nerve stimulation treatment, such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or implanted vagus nerve stimulation (VNS)
- People who have metal fragments in their body, implanted devices inside the skull, or fluid drainage tubes in the brain
- People with a serious general medical illness, such as severe anaemia requiring a blood transfusion, a high-grade heart rhythm problem, or severe heart muscle disease
- People who have active implanted medical devices, such as a cochlear implant, a cardiac pacemaker, or an implantable heart defibrillator
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Peter Falkai, MD, Max-Planck-Institute of Psychiatry
Phone: 0049-89-30622-1000
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from baseline in pupillometry; Change from baseline in 3-channel ECG; Change from baseline in skin conductance level; Change from baseline in photoplethysmography; Change from baseline in electrogastrogram; Change from baseline in the functional status of brainstem nuclei; Change from baseline in the response patterns in the reward anticipation task; Change from baseline in motor activity; Change from baseline in heart rate; Change from baseline in heart rate variability; Change from baseline in oxygen saturation; Change from baseline in skin temperature; Investigation of gene expressio...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.