A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
← catalyst calendarNCT03320304 · readout in 1,200 d
Sponsored by LivaNova (industry) · LIVN — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
500estimated
Sites
18
Countries
Austria, Belgium, Germany +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-12-14 | actual | When the study began enrolling |
| Primary completion | 2029-12-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-12-01 | estimated | The whole study's end, after follow-up |
| First posted | 2017-10-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Treatment Resistant Depression
Intervention
- Device: Vagal Nerve Simulation (VNS) Therapy
Primary outcome
what the primary-completion date above is the date OFThe primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant.
measured 12 months
Publications
- PMID 40021060 — linked by the registry
- PMID 38340111 — linked by the registry
- PMID 38194603 — linked by the registry
- PMID 32993573 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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