RECOVER: Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

RECOVER: Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Recruiting
18 years - 99 years
All
Phase N/A
30 participants needed
1 Location

Brief description of study

The research study is being conducted to determine if active VNS (Vagus Nerve Stimulation) Therapy helps depression subjects compared to a no-stimulation control group. This trial has is currently only recruiting bipolar subjects. Patients with an established diagnosis with Treatment-Resistant Depression (TRD), Bipolar I or II, and have been referred for treatment with the VNS Therapy® System will potentially qualify to participate in the study.
 
Final eligibility is based upon medical record review by the research investigator and the research team. 
 
All subjects in this study will receive a VNS Therapy implant and all subjects will receive active VNS Therapy. VNS Therapy was approved by the United States Food and Drug Administration (FDA) in 2005, on the basis of previous research, as a safe and effective add-on treatment for people with Treatment-Resistant Depression. VNS Therapy has been used to treat over 4,000 patients with Treatment-Resistant Depression in the US.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: depression,treatment resistant depression,bipolar disorder,vagus nerve stimulation
  • Age: 18 years - 99 years
  • Gender: All

  • At least 18 years of age or older
  • Current diagnosis of Bipolar I (current or most recent episode depressed) or Bipolar II
  • Current diagnosis of major depressive episode during which you have have inadequate benefit from at least 4 antidepressant treatments (psychotropic medication, TMS, ECT, psychotherapy, etc.)
  • Antidepressant treatments stable for at least 4 weeks

Updated on 04 Feb 2025. Study ID: 20-1258

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