A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
← catalyst calendarNCT03887715 · readout in 558 d
Sponsored by LivaNova (industry) · LIVN — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
6,800estimated
Sites
101
Country
United States
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 | 2019-09-26 | actual | When the study began enrolling |
| Primary completion | 2028-02-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-15 | 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: Vagus Nerve Stimulation (VNS) — also filed as VNS
Primary outcomes
what the primary-completion date above is the date OFMontgomery Åsberg Depression Rating Scale (MADRS) Rate of Response
measured 12 months post randomization
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response
measured Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission
measured Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response
measured Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission
measured Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response
measured Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission
measured Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission
measured Baseline up to 12 Months
Assess all Adverse Events
measured Implant to 12 Months
WHO Disability Assessment Schedule (WHODAS) Changes in scores over time
measured Baseline to 12 Months
Health Outcome Scale (EQ-5D-L) Changes in scores over time
measured Baseline to 12 Months
Clinical Global Impressions Scale - Improvement (CGI-I) Response
measured 12 months post randomization
Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality
measured Implant to 12 Months
Publications
- PMID 42447264 — linked by the registry
- PMID 41529263 — linked by the registry
- PMID 40673907 — linked by the registry
- PMID 39722333 — linked by the registry
- PMID 38574853 — 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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