Welcome!

News Feed Item

Neuronetics Announces Launch of First Ever Randomized, Controlled Clinical Trial to Evaluate Non-Drug NeuroStar TMS Therapy® in Adolescent Patients with Major Depressive Disorder

Study will Examine Acute and Long-Term Benefits of NeuroStar TMS, Including Symptom Reduction and Remission Rates

MALVERN, Pa., Nov. 2, 2015 /PRNewswire/ -- Neuronetics, Inc., the market leader in transcranial magnetic stimulation (TMS) technology, announced today the start of enrollment for a randomized controlled clinical trial to evaluate the acute and long-term effectiveness of NeuroStar TMS Therapy® in adolescent patients 12-21 years of age living with Major Depressive Disorder (MDD). This is the first randomized, controlled clinical trial to investigate treatment with TMS in adolescent patients with treatment resistant depression.  

Approximately 11 percent of adolescents living in the U.S. have been diagnosed with a depressive disorder.1 Although the disease state is a continuum into adulthood, symptoms in adolescents can differ from those seen in adult patients. Recognizable symptoms include complaints of feeling sick, refusal to participate in daily activities like going to school, misbehavior in the classroom and excessive worry of losing a caregiver.2

"The physical and emotional strain of Major Depressive Disorder can be debilitating for the youth living with it and for their families," said Christopher Thatcher, President and CEO of Neuronetics. "We are thankful that funding from a Series F Financing Round earlier this year, from GE Ventures and our other investors, will enable us to conduct this important clinical trial, which will further our understanding of the potential role of NeuroStar TMS Therapy in treating depression in adolescents."

The trial will evaluate the safety and efficacy of NeuroStar TMS in approximately 100 adolescent patients in study sites across the U.S. and Canada, using a six-week acute treatment course with follow-up after six months. Patients who do not improve have the option to enter the open label phase and receive known active TMS treatment. All who improve will then continue with the follow-up phase for six months, with TMS retreatment as necessary. 

"It is our hope that NeuroStar TMS Therapy will prove to be an effective treatment for managing the troubling symptoms and impairment associated with adolescent Major Depressive Disorder, which affects approximately 2.6 million young people in the United States. TMS is an appealing non-pharmacologic option with a promising tolerability profile that we hope to confirm in this study," said Dr. John Campo, Chair of the Department of Psychiatry and Behavioral Health at The Ohio State University College of Medicine and Wexner Medical Center. "Interested patients and their parents or caregivers are encouraged to speak with a healthcare provider to learn more about participating in this clinical trial."

For more information about the trial and enrollment, see ClinicalTrials.gov, identifier: NCT02586688 https://clinicaltrials.gov/ct2/show/NCT02586688?term=neurostar&rank=1.

About NeuroStar TMS Therapy 
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation. It stimulates nerve cells in the brain by delivering highly focused MRI-strength magnetic field pulses which lead to activation of cortical and deep brain structures known to be involved in mood regulation. The treatment is available by prescription and typically administered daily for 4-6 weeks.

The NeuroStar TMS Therapy System was initially FDA-cleared in 2008 on the basis of the largest randomized controlled trial evaluating TMS in depression.3 In an independent NIMH-sponsored randomized controlled trial, patients treated with TMS using a clinical trial version of the NeuroStar TMS System were four times more likely to achieve remission compared to patients receiving sham treatment (P=0.0173, odds ratio=4.05).4 The most common side effect of NeuroStar TMS Therapy is pain or discomfort at or near the treatment site. It is contraindicated in patients with non-removable conductive metal in or near the head.

More than 230 million people in the U.S. have access to insurance covering NeuroStar TMS Therapy. 

For full safety and prescribing information, visit www.NeuroStar.com

About Depression
Major Depressive Disorder is one of the most common mental disorders in the United States. It affects about 25 million Americans, and it's estimated that about four million patients do not benefit from standard treatments for depression, even after repeated treatment attempts. People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiousness, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems.

About Neuronetics, Inc.
Neuronetics, Inc., is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy®, a non-invasive form of neuromodulation. For more information, please visit www.neuronetics.com or www.neurostar.com.

NeuroStar®, NeuroStar TMS Therapy® and TMS Therapy® are registered trademarks of Neuronetics, Inc.

Media Contact:
Melissa Maycott
Tonic Life Communications
Office: 215-928-2192
Cell: 215-584-8782
[email protected]

1 J Am Acad Child Adolesc Psychiatry. 2010 October ; 49(10): 980–989. doi:10.1016/j.jaac.2010.05.017.
2 National Institute of Mental Health. (2014). Depression in Children and Adolescents Fact Sheet.
3 O'Reardon JP, et al. (2007). Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial. Biol Psychiatry, 62(11):1208-1216
4 George MS, et al. (2010). Daily Left Prefrontal Transcranial Magnetic Stimulation Therapy for Major Depressive Disorder: A Sham-Controlled Randomized Trial. Arch Gen Psychiatry, 67(5):507–516.

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/neuronetics-announces-launch-of-first-ever-randomized-controlled-clinical-trial-to-evaluate-non-drug-neurostar-tms-therapy-in-adolescent-patients-with-major-depressive-disorder-300169665.html

SOURCE Neuronetics, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software with the simplicity and reach of the open web. With staff in 10 timezones, Isomorphic provides a global network of services related to our technology, with offerings ranging from turnkey application development to SLA-backed enterprise support. Leadin...
While a hybrid cloud can ease that transition, designing and deploy that hybrid cloud still offers challenges for organizations concerned about lack of available cloud skillsets within their organization. Managed service providers offer a unique opportunity to fill those gaps and get organizations of all sizes on a hybrid cloud that meets their comfort level, while delivering enhanced benefits for cost, efficiency, agility, mobility, and elasticity.
DevOps has long focused on reinventing the SDLC (e.g. with CI/CD, ARA, pipeline automation etc.), while reinvention of IT Ops has lagged. However, new approaches like Site Reliability Engineering, Observability, Containerization, Operations Analytics, and ML/AI are driving a resurgence of IT Ops. In this session our expert panel will focus on how these new ideas are [putting the Ops back in DevOps orbringing modern IT Ops to DevOps].
Darktrace is the world's leading AI company for cyber security. Created by mathematicians from the University of Cambridge, Darktrace's Enterprise Immune System is the first non-consumer application of machine learning to work at scale, across all network types, from physical, virtualized, and cloud, through to IoT and industrial control systems. Installed as a self-configuring cyber defense platform, Darktrace continuously learns what is ‘normal' for all devices and users, updating its understa...
Enterprises are striving to become digital businesses for differentiated innovation and customer-centricity. Traditionally, they focused on digitizing processes and paper workflow. To be a disruptor and compete against new players, they need to gain insight into business data and innovate at scale. Cloud and cognitive technologies can help them leverage hidden data in SAP/ERP systems to fuel their businesses to accelerate digital transformation success.
Concerns about security, downtime and latency, budgets, and general unfamiliarity with cloud technologies continue to create hesitation for many organizations that truly need to be developing a cloud strategy. Hybrid cloud solutions are helping to elevate those concerns by enabling the combination or orchestration of two or more platforms, including on-premise infrastructure, private clouds and/or third-party, public cloud services. This gives organizations more comfort to begin their digital tr...
Most organizations are awash today in data and IT systems, yet they're still struggling mightily to use these invaluable assets to meet the rising demand for new digital solutions and customer experiences that drive innovation and growth. What's lacking are potent and effective ways to rapidly combine together on-premises IT and the numerous commercial clouds that the average organization has in place today into effective new business solutions.
Keeping an application running at scale can be a daunting task. When do you need to add more capacity? Larger databases? Additional servers? These questions get harder as the complexity of your application grows. Microservice based architectures and cloud-based dynamic infrastructures are technologies that help you keep your application running with high availability, even during times of extreme scaling. But real cloud success, at scale, requires much more than a basic lift-and-shift migrati...
David Friend is the co-founder and CEO of Wasabi, the hot cloud storage company that delivers fast, low-cost, and reliable cloud storage. Prior to Wasabi, David co-founded Carbonite, one of the world's leading cloud backup companies. A successful tech entrepreneur for more than 30 years, David got his start at ARP Instruments, a manufacturer of synthesizers for rock bands, where he worked with leading musicians of the day like Stevie Wonder, Pete Townsend of The Who, and Led Zeppelin. David has ...
Darktrace is the world's leading AI company for cyber security. Created by mathematicians from the University of Cambridge, Darktrace's Enterprise Immune System is the first non-consumer application of machine learning to work at scale, across all network types, from physical, virtualized, and cloud, through to IoT and industrial control systems. Installed as a self-configuring cyber defense platform, Darktrace continuously learns what is ‘normal' for all devices and users, updating its understa...
Dion Hinchcliffe is an internationally recognized digital expert, bestselling book author, frequent keynote speaker, analyst, futurist, and transformation expert based in Washington, DC. He is currently Chief Strategy Officer at the industry-leading digital strategy and online community solutions firm, 7Summits.
Addteq is a leader in providing business solutions to Enterprise clients. Addteq has been in the business for more than 10 years. Through the use of DevOps automation, Addteq strives on creating innovative solutions to solve business processes. Clients depend on Addteq to modernize the software delivery process by providing Atlassian solutions, create custom add-ons, conduct training, offer hosting, perform DevOps services, and provide overall support services.
Contino is a global technical consultancy that helps highly-regulated enterprises transform faster, modernizing their way of working through DevOps and cloud computing. They focus on building capability and assisting our clients to in-source strategic technology capability so they get to market quickly and build their own innovation engine.
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
Digital Transformation is much more than a buzzword. The radical shift to digital mechanisms for almost every process is evident across all industries and verticals. This is often especially true in financial services, where the legacy environment is many times unable to keep up with the rapidly shifting demands of the consumer. The constant pressure to provide complete, omnichannel delivery of customer-facing solutions to meet both regulatory and customer demands is putting enormous pressure on...