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New treatment option for Postpartum Depression (PPD)
Official title Investigation of TVNS Administration on Postpartum Mental Health
ClinicalTrials.gov ID: NCT06682689
What this study is testing
- What it's testing
- The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- No malformation of fetal organs (no abnormalities detected during "organ screening").
- Ability to provide written consent for themselves.
- Sufficient German language skills to communicate and understand study procedures.
You likely can't join if
- Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems...
- Cardiac arrhythmias or coronary heart disease.
- Neurological disorders.
- Current diagnosis or episode of a mood disorder.
- Diagnosed schizophrenia spectrum and other psychotic disorders.
- Severe substance use disorders.
See the full eligibility criteria
- No malformation of fetal organs (no abnormalities detected during "organ screening").
- Ability to provide written consent for themselves.
- Sufficient German language skills to communicate and understand study procedures.
- Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues).
- Cardiac arrhythmias or coronary heart disease.
- Neurological disorders.
- Current diagnosis or episode of a mood disorder.
- Diagnosed schizophrenia spectrum and other psychotic disorders.
- Severe substance use disorders.
- Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, 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.