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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03887715
The ClinicalTrials.gov registry entry for NCT03887715 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 6,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 248-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (2642% higher). The listed sponsor is LivaNova, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.