Abbott Launches Clinical Study for New Depression Treatment

Abbott has announced the launch of a new clinical trial, dubbed the TRANSCEND study, to better assess the company’s nascent new deep brain stimulation device (DBS) and its ability to manage difficult-to-treat depression – a frustrating form of major depressive disorder (MDD) that hasn’t reacted to at least two treatments.

The trial’s announcement comes on the heels of the company earning the U.S. Food and Drug Administration’s Breakthrough Device designation earlier this summer. The program accelerates regulatory review of emerging technologies designed to improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

The Breakthrough Device program, according to the FDA, “is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval.”

“As we’ve learned more about the intricacies of the brain, it’s now clear that ‘psychiatric diseases’ like major depressive disorder are similar to other neurological conditions – we can see identifiable structural and functional changes in the brain,” Brian Kopell, MD, lead neurosurgery investigator, and director of the Center for Neuromodulation and co-director of the Bonnie and Tom Strauss Center for Movement Disorders at Mount Sinai Health System said in a press release. “So, it’s not surprising that deep brain stimulation research has demonstrated promise for people suffering from treatment-resistant depression, as it has for patients with medically complicated Parkinson’s disease over the past two decades.”

Transcending Traditional Treatment

The TRANSCEND (Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS) study is a prospective, multi-centered, double-blind, randomized and sham-controlled clinical trial. The trial plans to enroll 100 participants between 22 to 70 years of age, who’ve failed a minimum of four different types of antidepressant treatments.

Abbott will randomly assign participants to the treatment or control arm of the trial. Once a participant has received their DBS device, Abbott will it activate for those in the treatment arm. Those in the control arm will not. Neither the participants nor those conducting the research will know whose DBS will be on.

Once a participant has completed 12 months in the study, all participants will have their DBS system turned on and followed for an additional two years. The study’s success will be evaluated based on the number of months participants in the treatment group experience improvements in their Montgomery-Asberg Depression Rating Scale (MADRS) scores compared to those in the control group. MADRS is used to measure a person’s depression by looking at a range of symptoms, such as sadness, loss of appetite, trouble sleeping, as well as difficulty concentrating and starting or completing daily tasks.

Difficult-to-treat Depression

Up to a third of MDD patients battle against difficult-to-treat depression. Research suggests that every time one of these patients doesn’t respond to a particular therapy, their odds of finding success with another one tumbles. After the fourth failed attempt, research shows that up to 84 percent of those patients will relapse.

DBS attacks the problem from a different angle. The device operates a lot like a pacemaker, firing off “small, targeted electrical pulses to a specific part of the brain to relieve symptoms.”

As part of the clinical trial, researchers plan to insert leads into the area of the brain that factors into depression. The leads connect to a “stimulator,” which researchers will place just under the skin in the chest. The stimulator will then send electrical pulses to the leads to adjust activity in the brain in an attempt to ease depression symptoms.

Earlier open-label studies exploring the use of DBS for TRD have shown at least a 50 percent sustained improvement in symptoms of depression for three out of four people. And these benefits persisted between two and eight years.

“Treatment-resistant depression is a debilitating condition affecting 2.8 million Americans each year,” Abbott VP of Neuromodulation Pedro Malha said. “The goal of [this[ 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.

Further Reading

Esmethadone Shows Potential in Difficult-to-Treat Depression

Algorithms for TRD Treatment Success

Barriers to Esketamine Nasal Spray Treatment Among Adults With Treatment-Resistant Depression