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..

42024/PRNewswire/--雅培（纽约证券交易所：ABT）今天宣布，它已经启动了一项关键的临床试验，称为TRANSCEND研究，以评估使用该公司的深部脑刺激（DBS）系统来管理难治性抑郁症（TRD），一种重性抑郁症。美国食品和药物管理局（FDA）授予雅培突破性设备指定，以探索在其突破性设备计划下使用DBS进行TRD，该计划加快了对创新技术的审查，这些技术可以改善威胁生命或不可逆转的衰弱疾病或状况的人的生活。。

'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.

西奈山医疗系统神经外科首席研究员、神经调节中心主任、邦妮和汤姆-施特劳斯运动障碍中心联合主任、医学博士布莱恩-科佩尔（Brian Kopell）说："随着我们对大脑复杂性的了解越来越多，现在很清楚，像重度抑郁症这样的‘精神疾病’与其他神经系统疾病类似--我们可以看到大脑中可识别的结构和功能变化。

'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.'.

因此，正如过去二十年来针对医学上复杂的帕金森氏病患者一样，大脑深部刺激研究已经证明对患有难治性抑郁症的患者有希望，这也就不足为奇了。我们迫切希望雅培的TRANSCEND试验能够收集更多关于神经刺激可能对需要不同治疗选择的人产生的影响的证据。

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 .

TRD是一种严重抑郁症（MDD），当一个人即使尝试了不同的抗抑郁方法（从谈话疗法到口服药物再到经颅磁刺激）也无法从症状中缓解时，就会发生TRD。高达三分之一的MDD患者（每年约280万美国人）患有TRD或难治性抑郁症。1每次治疗失败，下一次治疗缓解的机会就会下降，到第四次治疗失败时，多达83%的患者会复发。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.

DBS就像一个起搏器，向大脑的特定部位发送小的、有针对性的电脉冲，以缓解症状。作为TRANSCEND研究的一部分，医生将在大脑中影响抑郁症的区域放置电极（称为导联）。这些导线连接到一个称为刺激器的设备上，刺激器位于胸部皮肤下。

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.

刺激器会向导联发送电脉冲，目的是调整大脑活动，减轻与抑郁症相关的症状。以往探索使用 DBS 治疗 TRD 的开放标签研究显示，在 2 到 8 年的时间里，四分之三的患者的抑郁症状至少有 50%的持续改善。

'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.'.

雅培神经调节副总裁佩德罗·马尔哈（PedroMalha）说，难治性抑郁症是一种使人衰弱的疾病，每年影响280万美国人雅培超越研究的目标是与顶级临床研究中心合作，开发必要的临床证据，以确定DBS是否是治疗耐药性抑郁症的安全有效的治疗方法，这可以为人们提供一种新的治疗选择，使他们过上更充实的生活。”。

About TRANSCENDThe 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.

关于TRANSCEND TRANSCEND（治疗抵抗性抑郁症-扣带回下网络DBS）研究是一项前瞻性，多中心，双盲，随机和假对照临床试验。它将招收100名年龄在22至70岁之间的人，他们在全国多达25个中心至少四种不同类型的抗抑郁药治疗失败。

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..

。一旦参与者收到雅培DBS设备，治疗组的患者将打开系统，而对照组的患者则不会。参与者和研究人员都不知道他们的设备是否已打开。。

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.

一旦参与者完成了12个月的研究，所有参与者都将打开他们的DBS系统，并再随访两年。这项研究的成功将根据治疗组参与者与对照组相比蒙哥马利-阿斯伯格抑郁量表（MADRS）评分改善的月数进行评估。

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..

MADRS通过观察一系列症状来衡量一个人的抑郁程度，例如悲伤，食欲不振，睡眠困难，注意力不集中，开始或完成日常任务。。

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

Brian Kopell博士为雅培的神经调节业务咨询了DBS技术。

About AbbottAbbott 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..

AbbottAbbott是一家全球医疗保健领导者，致力于帮助人们在生命的各个阶段都生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域，拥有诊断、医疗器械、营养品和品牌仿制药领域的领先业务和产品。我们的114000名同事为160多个国家的人民服务。。