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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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