Emory University has joined a national clinical trial that is investigating deep brain stimulation (DBS) as a potential treatment for individuals with treatment-resistant depression (TRD). The study, known as the TRANSCEND clinical trial, is a randomized placebo-controlled investigation being conducted at 25 sites across the United States. It aims to evaluate the safety and effectiveness of Abbott’s DBS system for patients who have not responded to standard therapies.
The first patient in the Emory arm of the trial received treatment on July 28 at Emory University Hospital. Additional participants are currently being enrolled. Emory was selected for its expertise in neurosurgery and psychiatric care for severe depression.
“Emory has been a leader in DBS research for decades, and we’re proud to be part of this important new study,” said 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.”
According to estimates, about 2.8 million Americans experience TRD each year. This form of major depressive disorder is diagnosed after several unsuccessful attempts with medication, psychotherapy, or other interventions. As more treatments fail, it becomes harder for patients to achieve symptom improvement or long-term recovery.
“This clinical trial builds on Emory’s longstanding leadership in neuromodulation for complex neurological and psychiatric conditions, including treatment-resistant depression,” said Nicholas Au Yong, MD, PhD, associate professor of Neurosurgery, Cell Biology and Biomedical Engineering 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 has been approved by the FDA for nearly three decades as a therapy for movement disorders such as Parkinson’s disease and essential tremor. Abbott has received Breakthrough Device designation from the FDA to study its use in TRD; however, it is not yet approved specifically for treating depression.
In this trial, surgeons implant electrodes into specific brain regions involved in mood regulation along with battery-powered pulse generators under the skin near the chest. These devices send electrical signals intended to influence brain areas associated with depression symptoms.
More information about this ongoing study can be found at https://clinicaltrials.gov/.
