Fairlawn

Researchers are studying the use of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for people with treatment-resistant depression. The study aims to find out if active VNS therapy can reduce the severity of depression symptoms compared to no stimulation over a 12-month period. This is a randomized, controlled, and blinded trial involving subjects implanted with the VNS device. Participants are randomly assigned to one of two groups: one group will have the VNS device activated two weeks after implantation, while the other group will have the device implanted but not activated for the first 12 months. After 12 months, those in the control group may receive stimulation. After completing the 12-month randomized portion, all subjects can join an open-label, longer-term study lasting about 5 years to continue monitoring. During the study, participants will undergo assessments using several depression rating scales at regular intervals, including the Montgomery Åsberg Depression Rating Scale (MADRS), with evaluation of response, remission, and duration of effects. Additional measures include assessments of disability, health outcomes, clinical global impressions, and suicidality tracking. Safety and adverse events are also monitored from implantation through 12 months.