HQ Team
September 4, 2024: Abbott Laboratories has initiated a clinical trial to evaluate the use of the company’s deep brain stimulation system to manage treatment-resistant depression, a form of major depressive disorder.
The system works like a pacemaker, sending small, targeted electrical pulses to a specific part of the brain to relieve symptoms, according to a company statement.
As part of the trial, dubbed TRANSCEND, 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 of the chest.
The stimulator will send electrical pulses to the leads to adjust activity in the brain and reduce symptoms associated with depression.
Previous open-label studies exploring the use of deep brain stimulation for treatment-resistant depression have shown about a 50% sustained improvement in symptoms of depression for three out of four people over two to eight years.
Parkinson’s disease
While Abbott’s DBS system has traditionally been used to help control symptoms for people with movement disorders, such as Parkinson’s disease and essential tremor, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of treatment-resistant depression.
The US Food and Drug Administration granted Breakthrough Device Designation to investigate the use of its deep brain stimulation system in July 2022. Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
“As we have learned more about the intricacies of the brain, it is 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,” said Brian Kopell, MD, lead neurosurgery investigator, director of the Center for Neuromodulation and co-director at Mount Sinai Health System,
“So, it is 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.
“We are eager for Abbott’s trial to gather further evidence about the impact neurostimulation could have for people who need different treatment options than are currently available.”
Talk therapy, oral medications
A form of major depressive disorder, treatment-resistant depression 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 the disorder – about 2.8 million Americans each year – have treatment-resistant depression 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, according to the statement.
It is a “debilitating condition,” said Pedro Malha, vice president, of neuromodulation, at Abbott.
“The goal of Abbott’s study, in collaboration with top clinical research centres, is to develop the clinical evidence necessary to determine whether deep brain stimulation 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.”
MADRS scores
The trial will enrol 100 people, ages 22 to 70, who have failed a minimum of four different types of antidepressant treatments at up to 25 centres nationwide.
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.
Treatment-resistant depression disorder costs the U.S. approximately $44 billion a year in healthcare, unemployment and lost productivity1, deep brain stimulation has the potential to offer meaningful improvement of depressive symptoms, according to the statement.
Currently, physicians have access to a range of treatments for the disease, also called clinical depression, including antidepressant medications and device therapies.
