VNS Therapy for Treatment-Resistant Depression
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
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 6,800 (estimated)
- Sponsor
- LivaNova · Industry
This trial is looking for adults with treatment-resistant depression. Participants will receive either active VNS therapy or a control without stimulation to see how it affects their depression over 12 months.
You may be able to join if
- I have been diagnosed with major depressive disorder for at least two years.
- I have had at least four episodes of major depressive disorder.
- I have tried four failed treatments for my depression.
- I am currently experiencing a major depressive episode.
- I have a stable medication routine for at least four weeks before starting.
You may not be able to join if
- I have a history of psychotic features in any depressive episode.
- I have a history of schizophrenia or schizoaffective disorder.
- I have a history of any other psychotic disorder.
- I have rapid cycling bipolar disorder.
- I have a cognitive disorder like dementia or delirium.
- I have current suicidal intent.
- I am using another investigational device or drugs.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your EligibilityObjectives 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.
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