Abbott Initiates Clinical Study to Evaluate the Use of Its Deep Brain Stimulation System to Manage Severe Depression

Rhea-AI Summary

Abbott (NYSE: ABT) has initiated the TRANSCEND study, a pivotal clinical trial evaluating the use of its deep brain stimulation (DBS) system for treatment-resistant depression (TRD). The U.S. FDA granted Abbott Breakthrough Device designation for this research. TRD affects approximately 2.8 million Americans annually, with up to a third of major depressive disorder patients experiencing treatment resistance.

DBS works like a pacemaker, sending targeted electrical pulses to specific brain areas to relieve symptoms. Previous open-label studies have shown at least a 50% sustained improvement in depression symptoms for three out of four people over two to eight years. The TRANSCEND study aims to gather evidence on the impact of neurostimulation for TRD patients who have not responded to conventional treatments.

Positive

• FDA granted Abbott Breakthrough Device designation for DBS in TRD
• Initiation of pivotal clinical trial (TRANSCEND study) for DBS in TRD
• Previous open-label studies showed 50% sustained improvement in depression symptoms for 75% of participants over 2-8 years

Negative

• None.

Insights

Medical Research Analyst

Abbott's initiation of the TRANSCEND study for Deep Brain Stimulation (DBS) in Treatment-Resistant Depression (TRD) is a significant development in the field of neuropsychiatry. The FDA's Breakthrough Device designation underscores the potential impact of this technology. With 33% of Major Depressive Disorder patients experiencing TRD, affecting 2.8 million Americans annually, the need for innovative treatments is critical.

The study's focus on DBS, which has shown promise in previous open-label studies with a 50% sustained improvement in symptoms for 3 out of 4 people over 2-8 years, could revolutionize TRD treatment. However, it's important to note that these are early-stage results and the TRANSCEND study will provide more robust evidence on efficacy and safety.

If successful, this could offer hope to patients who have exhausted conventional treatments, potentially reducing the high relapse rates associated with TRD.

Neurology Expert

Abbott's TRANSCEND study represents a paradigm shift in our approach to treating depression. By applying DBS technology, previously successful in movement disorders like Parkinson's, to TRD, we're acknowledging the neurological basis of psychiatric conditions. This aligns with emerging research showing structural and functional brain changes in depression.

The study's design, targeting specific brain areas involved in depression, could provide valuable insights into the neural circuits underlying mood disorders. However, it's important to consider potential risks and side effects associated with brain surgery and long-term stimulation.

If proven effective, this approach could dramatically improve quality of life for TRD patients, reducing the economic and social burden of this condition. It may also pave the way for similar applications in other treatment-resistant psychiatric disorders.

Market Research Analyst

Abbott's venture into the TRD market with DBS technology presents a significant business opportunity. With 2.8 million potential patients annually in the U.S. alone, the market size is substantial. Given the high relapse rates and effective treatments for TRD, a successful DBS solution could capture a considerable market share.

The FDA's Breakthrough Device designation could accelerate the path to market, potentially giving Abbott a first-mover advantage in this space. This could strengthen Abbott's position in the neuromodulation market, diversifying its portfolio beyond traditional applications like movement disorders.

However, investors should consider the long development timeline typical for medical devices, potential regulatory hurdles and the need for extensive clinical evidence to support adoption. The success of this venture could significantly impact Abbott's long-term growth prospects in the rapidly evolving field of neurotechnology.

• The U.S. FDA granted Abbott Breakthrough Device designation to explore deep brain stimulation (DBS) for treatment-resistant depression (TRD) as an option to improve the lives of people with this debilitating condition
• Approximately 2.8 million Americans each year are diagnosed with TRD, a form of major depressive disorder that has not responded to two or more treatments¹ 

ABBOTT PARK, Ill., Sept. 4, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) 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.

"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, M.D., 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. "So, it is not surprising that deep brain stimulation research has demonstrated promise for people suffering with 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 TRANSCEND trial to gather further evidence about the impact neurostimulation could have for people who need different treatment options than are currently available."

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.¹ 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.¹ 

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.²

"Treatment-resistant depression is a debilitating condition affecting 2.8 million Americans each year," said Pedro Malha, vice president, neuromodulation, Abbott. "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."

About TRANSCEND
The TRANSCEND (Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS) study is a prospective, multi-centered, double-blind, randomized and sham-controlled clinical trial. It will enroll 100 people, ages 22 to 70, who have failed a minimum of four different types of antidepressant treatments at up to 25 centers nationwide. Participants will be randomly assigned to either the treatment arm or control arm of the trial. Once a participant has received their Abbott DBS device, those in the treatment arm will have the system turned on while those in the control arm will not. Neither the participant nor the study researcher will know if their device has been turned 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.

Dr. Brian Kopell has consulted on DBS technology for Abbott's neuromodulation business.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

1 Rush AJ, Trivedi, MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-1917. doi:10.1176/ajp.2006.163.11.1905. 2 Crowell AL, Riva-Posse P, Holtzheimer PE, et al. Long-Term Outcomes of Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression. Am J Psychiatry. 2019;176(11):949-956. doi:10.1176/appi.ajp.2019.18121427.

 

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SOURCE Abbott

FAQ

What is the purpose of Abbott's TRANSCEND study for ABT stock?

The TRANSCEND study aims to evaluate the use of Abbott's deep brain stimulation (DBS) system for treating treatment-resistant depression (TRD), potentially opening a new market for Abbott's neuromodulation products.

How many Americans are affected by treatment-resistant depression annually?

Approximately 2.8 million Americans are diagnosed with treatment-resistant depression (TRD) each year, representing a significant potential market for Abbott's DBS system if proven effective.

What is the significance of the FDA's Breakthrough Device designation for Abbott's DBS system?

The FDA's Breakthrough Device designation for Abbott's DBS system in TRD expedites the review process, potentially accelerating market entry and giving Abbott a competitive advantage in this therapeutic area.

What were the results of previous studies on DBS for treatment-resistant depression?

Previous open-label studies showed at least a 50% sustained improvement in depression symptoms for three out of four people over a period of two to eight years, indicating promising potential for Abbott's DBS system in TRD treatment.