Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03887715 · ClinicalTrials.gov registry record · NA
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
A NA study of Treatment-Resistant Depression, sponsored by LivaNova.
- Recruiting
- Registry status
- NA
- Development phase
- 6,800
- Enrollment target
- 20
- Study locations
NCT03887715: Recruiting NA study of Treatment-Resistant Depression, sponsored by LivaNova.
NCT03887715 is a NA study of Treatment-Resistant Depression that is actively recruiting participants, run by LivaNova. The registered enrollment target is 6,800 participants, above the 248-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (2642% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887715, a NA study of Treatment-Resistant Depression, is actively recruiting participants, sponsored by LivaNova.
- RECRUITING
- Registry status
- NA
- Development phase
- 6,800 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.
Conditions Studied
Interventions
- DEVICE Vagus Nerve Stimulation (VNS)
Study Locations (20)
Florida
- Sunrise Research Institute - Boca Raton
- Mindful Behavioral Health - Boca Raton
- Medycal Research, Inc - Brooksville
- Galiz Research LLC - Hialeah
- Florida Behavioral Psych - Largo
- Segal Trials Corporate - Lauderhill
- Central Miami Medical Institute, LLC - Miami
- Clintex Research Group, Inc. - Miami
- Research Center Of Florida, Inc - Miami
- Ocean Blue Medical Research Center - Miami Springs
California
- Access Multi Specialty Medical Clinic, Inc - Burlingame
- CMB Clinical Trials - Colton
- ATP Clinical Research, Inc. - Costa Mesa
- Kaizen Brain Center - La Jolla
- Keck Hospital of USC - Los Angeles
- University of California San Diego - San Diego
- SF-CARE, Inc. - San Rafael
- Syrentis Clinical Research - Santa Ana
Alabama
- University of Alabama at Birmingham - Birmingham
- UAB Huntsville Regional Medical Center - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,800 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
What NCT03887715 shows while recruiting
NCT03887715 is an interventional study that assigns participants to a tested intervention. Its 6,800 participants enrollment target places it among the larger protocols in the corpus, above the 248-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (2642% higher).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Vagus Nerve Stimulation (VNS) is the first listed.
NCT03887715 names 20 study sites across 3 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03887715 about?
NCT03887715 is a clinical study titled "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". 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.
What is the current status of trial NCT03887715?
This trial is currently recruiting. It is a NA study. The enrollment target is 6,800 participants. The study started on 2019-09-26. Estimated completion is 2030-12-31.
What conditions does trial NCT03887715 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT03887715?
The interventions under investigation include: Vagus Nerve Stimulation (VNS) (DEVICE).
Who is sponsoring clinical trial NCT03887715?
This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03887715 being conducted?
This trial has 20 study locations across Alabama, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-Resistant Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03887715's enrollment target sits among peer trials
6,800 1st of 54 higher than 54 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
RECRUITING · NA
-
Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
RECRUITING · NA
-
DBS for TRD With the Medtronic Percept PC
RECRUITING · NA
-
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
RECRUITING · NA
-
PCS in Severe Treatment Resistant Depression
RECRUITING · NA
-
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06234384 · 6,833 participants
Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)
- NCT05121324 · 6,700 participants · Phase 3
Pediatric Dose Optimization for Seizures in Emergency Medical Services
- NCT06272045 · 6,618 participants · NA
Early Intervention to Promote Cardiovascular Health of Mothers and Children
- NCT00260585 · 7,000 participants
Esophageal Cancer Risk Registry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI