Abbott announced today it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company's deep brain stimulation (DBS) system to manage treatment-resistant depression (TRD), a form of major depressive disorder. The U.S. Food and Drug Administration (FDA) granted Abbott Breakthrough Device designation to explore use of DBS for TRD under its Breakthrough Devices Program, which expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
A form of major depressive disorder (MDD), TRD occurs when a person has not been able to find relief from their symptoms even after trying different antidepressant approaches, which can range from talk therapy to oral medications to transcranial magnetic stimulation. Up to a third of individuals diagnosed with MDD – approximately 2.8 million Americans each year – have TRD or difficult-to-treat depression. Each time a person fails a treatment, the chance of finding relief with the next treatment drops, and by the fourth failed treatment, as many as 83% of patients will relapse.
DBS works like a pacemaker, sending small, targeted electrical pulses to a specific part of the brain with the goal of relieving symptoms. As part of the TRANSCEND study, doctors will place electrodes – called leads – in an area of the brain that impacts depression. These leads are connected to a device called a stimulator that is placed under the skin in the chest. The stimulator will send electrical pulses to the leads with the goal of adjusting activity in the brain and reducing symptoms associated with depression. Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.
