Emory University has joined a new national clinical trial exploring the use of deep brain stimulation (DBS) for treatment-resistant depression (TRD), expanding its efforts to improve outcomes for patients who have not responded to conventional therapies.
The study is part of the TRANSCEND clinical trial, a randomized placebo-controlled, multi-site national investigation that is evaluating the safety and effectiveness of healthcare company Abbott’s DBS system for individuals with TRD. Emory is one of 25 sites nationwide participating in the trial, selected for its expertise in both neurosurgical technique and the psychiatric care of patients with severe, treatment-resistant depression.
The first patient enrolled in the trial at Emory was treated on July 28 at Emory University Hospital, with additional patients currently being enrolled, marking the latest milestone in Emory’s pioneering leadership in neuromodulation and brain health research.
“Emory has been a leader in DBS research for decades, and we’re proud to be part of this important new study,” says Patricio Riva-Posse, MD, associate professor and director of the Interventional Psychiatry Service in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine and principal investigator for Emory. “The previous open-label studies we have conducted since 2007 at Emory using DBS to treat depression show significant and durable antidepressant effects. This new clinical trial will help us build on that foundation to better understand who may benefit most and why.”
An estimated 2.8 million Americans are affected each year by TRD, a severe and often overlooked form of major depressive disorder. TRD is typically diagnosed after multiple treatment attempts, such as medication, psychotherapy or other interventions have failed to provide relief. The likelihood of symptom improvement declines with each unsuccessful treatment, making long-term recovery especially challenging for those living with the condition.
“This clinical trial builds on Emory’s longstanding leadership in neuromodulation for complex neurological and psychiatric conditions, including treatment-resistant depression,” says Nicholas Au Yong, MD, PhD, associate professor of Neurosurgery, Cell Biology and Biomedical Engineering, implanting neurosurgeon at Emory and co-investigator. “It is made possible through close collaboration between neurosurgery and psychiatry, united by the goal of developing more effective therapies and offering meaningful hope to patients facing the most severe forms of depression. The need is urgent, and advancing this research is essential to changing the course of the disease.”
DBS is an FDA-approved therapy that has been used for nearly 30 years to help manage movement disorders such as Parkinson’s disease and essential tremor. Abbott received Breakthrough Device designation from the FDA to study DBS as a potential treatment for TRD, but it is not currently approved for this use.
During the trial, neurosurgeons place electrodes in targeted areas of the brain involved in mood regulation, along with implantable pulse generators (IPG)— battery-powered stimulators placed under the skin of the chest. The system sends controlled electrical signals to brain regions believed to be linked to depression, similar to how a pacemaker works.
An estimated 2.8 million Americans are affected each year by TRD, a severe and often overlooked form of major depressive disorder. TRD is typically diagnosed after multiple treatment attempts, such as medication, psychotherapy or other interventions have failed to provide relief. The likelihood of symptom improvement declines with each unsuccessful treatment, making long-term recovery especially challenging for those living with the condition.
Please visit clinicaltrials.gov more information on the study.