NCT07097025Completed
2-Year Study of Vagus Nerve Stimulation for Higher-Grade Treatment-Resistant Depression: Clinical Outcomes and Policy Recommendation
Efficacy and Safety of Vagus Nerve Stimulation Treatment in Treatment Resistant Depression
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
The goal of this observational study is to evaluate whether vagus nerve stimulation (VNS) intervention can reduce depressive symptoms and suicidality in adults with higher-grade treatment-resistant depression (HG-TRD)-individuals who have not responded to at least four prior depression treatments. The main questions it aims to answer are: does VNS lead to a meaningful and sustained reduction in depression severity over 24 months? and does VNS reduce suicidal thoughts and behaviors in this population? Participants in this study were adults (age ≥ 18) with chronic or recurrent depression and at least four failed prior treatments, including medication, psychotherapy, electroconvulsive therapy (ECT), or esketamine. They underwent surgical implantation of a VNS device and their depressive symptoms and suicidality assessed at baseline, and then again at 6, 12, 18, and 24 months using the Montgomery-Åsberg Depression Rating Scale (MADRS). The study includes continous follow-upvisits and VNS device adjustments for 2 years post implantation. with outcomes including treatment response, remission, changes in suicidal ideation, and psychiatric hospitalization days over the study period
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 19 (actual)
- First submitted
- 24 Jul 2025
- Start date
- 1 Jan 2020
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Dr.Yoav Domany
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT07097025
What you commit to
- Study type: Observational
- Participants enrolled: 19
- From 1 Jan 2020 to the primary completion date, 30 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Lifetime history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder and other) or psychotic features during the current depressive episode.
- Lifetime history of rapid-cycling bipolar disorder.
Who the study is looking for
- age ≥ 18 years.
- Diagnose of chronic and recurrent depressive episode lasting at least two years (persistent depressive disorder) or a history of at least three depressive episodes, including the current episode, according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria.
- Resistance to treatment was defined as failure to respond to at least four antidepressant treatments, including pharmacotherapy (administered at therapeutic dosages for at least four weeks), psychotherapy, Electroconvulsive treatment (ECT), or esketamine meaning HD-TRD.
- Baseline scores \>20 according to the Montgomery-Åsberg Depression Rating Scale (MADRS) (indicating moderate (20-34) to severe (\>34) depression).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maaynei Hayeshua medical center Coordinator of this site? Confirm its status | Bnei Brak | Israel | Unknown status |
| Lev Hasharon Medical Center Coordinator of this site? Confirm its status | Netanya | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.