Abbott Initiates Clinical Study to Evaluate the Use of Its Deep Brain Stimulation System to Manage Severe Depression
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.
Abbott (NYSE: ABT) ha avviato lo studio TRANSCEND, un trial clinico fondamentale che valuta l'uso del suo sistema di stimolazione cerebrale profonda (DBS) per la depressione resistente al trattamento (TRD). La FDA statunitense ha concesso ad Abbott la designazione di Dispositivo Innovativo per questa ricerca. La TRD colpisce circa 2,8 milioni di americani ogni anno, con fino a un terzo dei pazienti affetti da disturbo depressivo maggiore che vivono una resistenza al trattamento.
Il DBS funziona come un pacemaker, inviando impulsi elettrici mirati a specifiche aree del cervello per alleviare i sintomi. Studi precedenti a etichetta aperta hanno mostrato un miglioramento sostenuto dei sintomi depressivi di almeno 50% per tre persone su quattro nel corso di due a otto anni. Lo studio TRANSCEND mira a raccogliere prove sull'impatto della neurostimolazione per i pazienti TRD che non hanno risposto ai trattamenti convenzionali.
Abbott (NYSE: ABT) ha iniciado el estudio TRANSCEND, un ensayo clínico fundamental que evalúa el uso de su sistema de estimulación cerebral profunda (DBS) para la depresión resistente al tratamiento (TRD). La FDA de EE. UU. otorgó a Abbott la designación de Dispositivo Innovador para esta investigación. La TRD afecta aproximadamente a 2.8 millones de estadounidenses anualmente, con hasta un tercio de los pacientes con trastorno depresivo mayor experimentando resistencia al tratamiento.
El DBS funciona como un marcapasos, enviando pulsos eléctricos dirigidos a áreas específicas del cerebro para aliviar los síntomas. Estudios anteriores en abierto han mostrado al menos una mejora sostenida del 50% en los síntomas de depresión para tres de cada cuatro personas durante un período de dos a ocho años. El estudio TRANSCEND tiene como objetivo recopilar evidencia sobre el impacto de la neuroestimulación en pacientes con TRD que no han respondido a los tratamientos convencionales.
Abbott (NYSE: ABT)는 TRANSCEND 연구를 시작했습니다. 이는 치료 저항성 우울증(TRD)을 위한 심부 뇌 자극(DBS) 시스템의 사용을 평가하는 중요한 임상 시험입니다. 미국 FDA는 이 연구에 대해 Abbott에 획기적인 기기 지정을 부여했습니다. TRD는 매년 약 280만 명의 미국인에게 영향을 미치며, 주요 우울 장애 환자의 약 3분의 1이 치료 저항성을 경험합니다.
DBS는 심박조율기처럼 작동하여 증상을 완화하기 위해 특정 뇌 영역에 전기 신호를 보냅니다. 이전의 개방형 연구에서 무려 50% 이상의 지속적인 우울증 증상 개선이 4명 중 3명에게 나타난 것으로 보여졌습니다. TRANSCEND 연구는 기존 치료에 반응하지 않는 TRD 환자에 대한 신경 자극의 영향을 파악하기 위해 증거를 수집하는 것을 목표로 하고 있습니다.
Abbott (NYSE: ABT) a lancé l'étude TRANSCEND, un essai clinique décisif évaluant l'utilisation de son système de stimulation cérébrale profonde (DBS) pour la dépression résistante au traitement (TRD). La FDA américaine a accordé à Abbott la désignation de Dispositif Innovant pour cette recherche. La TRD touche environ 2,8 millions d'Américains chaque année, avec jusqu'à un tiers des patients souffrant de trouble dépressif majeur éprouvant une résistance au traitement.
Le DBS fonctionne comme un pacemaker, envoyant des impulsions électriques ciblées vers des zones spécifiques du cerveau pour soulager les symptômes. Des études précédentes à étiquette ouverte ont montré au moins une amélioration durable de 50% des symptômes dépressifs chez trois personnes sur quatre sur une période de deux à huit ans. L'étude TRANSCEND vise à recueillir des preuves sur l'impact de la neurostimulation chez les patients TRD qui n'ont pas répondu aux traitements conventionnels.
Abbott (NYSE: ABT) hat die TRANSCEND-Studie initiiert, eine wegweisende klinische Studie zur Bewertung der Anwendung seines Systems zur tiefen Hirnstimulation (DBS) bei behandlungsresistenter Depression (TRD). Die US-amerikanische FDA hat Abbott die Breakthrough-Gerätebezeichnung für diese Forschung verliehen. TRD betrifft jährlich etwa 2,8 Millionen Amerikaner, wobei bis zu ein Drittel der Patienten mit einer schweren depressiven Störung eine Behandlungsresistenz aufweisen.
DBS funktioniert wie ein Herzschrittmacher, indem es gezielte elektrische Impulse an bestimmte Gehirnareale sendet, um Symptome zu lindern. Frühere offene Studien haben gezeigt, dass es bei drei von vier Personen über einen Zeitraum von zwei bis acht Jahren mindestens eine 50%ige nachhaltige Verbesserung der Depressionssymptome gab. Die TRANSCEND-Studie zielt darauf ab, Beweise für die Auswirkungen der Neurostimulation bei TRD-Patienten zu sammeln, die nicht auf konventionelle Behandlungen angesprochen haben.
- 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
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Insights
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
The study's focus on DBS, which has shown promise in previous open-label studies with a
If successful, this could offer hope to patients who have exhausted conventional treatments, potentially reducing the high relapse rates associated with TRD.
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.
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
"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
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
"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. | ||||
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