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Life sciences · Interventional Study
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT03887715). This is a study registration, not published results. Lead sponsor: LivaNova. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 6800 participants (ESTIMATED). Conditions: Treatment Resistant Depression. Interventions: DEVICE: Vagus Nerve Stimulation (VNS). Primary outcome measures: Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response , 12 months post randomization; Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response , Baseline up to 12 Months; Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission , Baseline up to 12 Months; Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response , Baseline up to 12 Months; Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission , Baseline up to 12 Months; Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response , Baseline up to 12 Months; Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission , Baseline up to 12 Months; Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission , Baseline up to 12 Months; Assess all Adverse Events , Implant to 12 Months; WHO Disability Assessment Schedule (WHODAS) Changes in scores over time , Baseline to 12 Months; Health Outcome Scale (EQ-5D-L) Changes in scores over time , Baseline to 12 Months; Clinical Global Impressions Scale - Improvement (CGI-I) Response , 12 months post randomization; Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality , Implant to 12 Months. Brief summary: Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.