This study aims to recruit a large population of adults with treatment resistant depression in order to track and compare results for two patient groups – one managed with and one managed without added vagus nerve stimulation (VNS) therapy. (See “Treatment-Resistant Depression Registry” on ClinicalTrials.gov )
VNS employs a small implant that delivers mild pulses to the vagus nerve, stimulating production of serotonin and other neurotransmitters involved in mood. (For more information and a video, click here.)
The objective of the large study/registry is to better understand the benefits of VNS, factors likely to affect any benefits, time required for improvement or remission, etc.
To be eligible, patients must be currently in a major depressive episode. And for the purposes of this study, treatment resistant depression is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times, to include the current episode, during the patient's lifetime AND has not adequately responded to 4 or more adequate antidepressive treatments.
• Before the patient is enrolled in the registry, patients and their physicians will determine the course of treatment and whether the patient will receive VNS therapy or not. The stimulation device is implanted. (So at least 500 patients will receive VNS therapy and about 500 will not receive VNS therapy.)
• The cost of implantation is not covered by the study sponsor, though the Case Management team “can assist the referring psychiatrist with the insurance prior-authorization process.”
• The study will then follow the clinical course and outcomes for patients with TRD who are treated with and without adjunctive VNS therapy (24 and 60 months, respectively).
For more details, to review the 37 study locations now recruiting, and to find contact information for each location, see the ClinicalTrials.gov listing for “Treatment-Resistant Depression Registry,” ID # NCT00320372