Abbott Begins Trial of Deep Brain Stimulation for Treatment-Resistant Depression

Abbott has begun a pivotal clinical trial, the TRANSCEND study, to evaluate its deep brain stimulation (DBS) system to manage treatment-resistant depression (TRD).
 
The U.S. Food and Drug Administration awarded Abbott breakthrough device designation to explore using DBS for TRD in 2022.
 
TRD is a form of major depressive disorder (MDD) and occurs when a patient hasn’t found relief from symptoms even after attempting different antidepressant approaches like talk therapy, oral medications, or transcranial magnetic stimulation. About a third of those diagnosed with major depression (approximately 2.8 million Americans each year) have TRD or difficult-to-treat depression. Each time a treatment fails, the chance of getting relief with the next treatment drops.
 
DBS sends small, targeted pulses to a specific brain area with the goal of relieving symptoms. The TRANSCEND study will involve placement of leads in the brain area that impacts depression. These connect to a stimulator placed under the skin in the chest, which sends electrical pulses to the leads to adjust brain activity and reduce symptoms related to depression.
 
TRANSCEND (Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS) will enroll 100 people ages 22-70 who have failed at least four different antidepressant treatments at up to 25 centers nationwide.
 
Patients will be randomly assigned to the trial’s treatment or control arm. Once a subject has received the Abbott DBS device, those in the treatment arm will have the system switched on while those in the control arm won’t. Neither participant nor study researcher will know if their device was turned on.
 
Once a participant has completed 12 months in the study, all will have their DBS system turned on and followed for a further two years. The study’s success will be evaluated based on the number of months participants in the treatment group have improvements in their Montgomery-Asberg Depression Rating Scale (MADRS) scores compared to those in the control group.
 
MADRS is used to measure depression by looking at a variety of symptoms, such as sadness, loss of appetite, trouble sleeping, as well as difficulty concentrating and starting or completing daily tasks.
 
“Treatment-resistant depression is a debilitating condition affecting 2.8 million Americans each year,” said Abbott VP of neuromodulation Pedro Malha. “The goal of Abbott’s TRANSCEND study, in collaboration with top clinical research centers, is to develop the clinical evidence necessary to determine whether DBS is a safe and effective treatment for treatment-resistant depression, which could provide people with a new treatment option that will allow them to live fuller lives.”