NeuroStar® Patient Outcomes Registry Has Now Surpassed 3,000 Evaluable Patients, Making It The World's Largest in Major Depressive Disorder
MALVERN, Pa., July 8, 2019 /PRNewswire/ -- Neuronetics, Inc. (NASDAQ: STIM) – Neuronetics, Inc., the developer of NeuroStar® Advanced Therapy, announced today that its depression outcomes registry has reached 3,223 evaluable patients, making it the largest outcomes registry in the world for Major Depressive Disorder (MDD). Launched in November 2016 for the purpose of collecting and analyzing outcomes data from treatment with NeuroStar Advanced Therapy in real-word clinical settings, the registry has surpassed the number of evaluable patients in the STAR*D study (n=2,876), making it the largest registry focused on therapies for the treatment of depression. STAR*D was previously the largest long-term study directly comparing treatment strategies for patients with depression. The NeuroStar outcomes registry includes data from 100 clinical practice sites across the the United States and reveals that the majority of patients (63 percent) treated with NeuroStar Advanced Therapy experienced significant improvement* in their depression symptoms, supporting real-world outcomes consistent with those results seen in an open-label clinical trial (Carpenter 2012) in which 58 percent of patients experienced significant improvement.1 Safety data reported in the registry is also consistent with the findings of previously conducted clinical trials.
"This clinical evidence continues to indicate that NeuroStar is an effective, non-drug depression treatment option. As MDD continues to be a major issue for people in the U.S. and across the globe, a proven option like this is more critical than ever," said Dr. Todd Hutton of Southern California TMS Center and 2019-2020 President of the International Clinical TMS Society. "I am extremely proud to be a part of the NeuroStar outcomes registry and helping to achieve this milestone, as it further underscores a commitment to understanding safe and effective treatment strategies with the potential to help millions achieve remission. It is exciting to use NeuroStar to transform lives and to contribute to an outcomes registry that could provide insight into potential future TMS applications and development."
Depression impacts more than 17 million adults in the U.S.2 For many people, antidepressant medication is ineffective, demonstrating the importance of breakthrough treatment options and innovative research to address the unmet needs of this population. The NeuroStar outcomes registry aims to investigate and better understand the use of NeuroStar, a non-drug depression treatment, in a clinical setting.
"Surpassing this 3,000-patient milestone in the registry further validates NeuroStar Advanced Therapy's efficacy for patients struggling with depression and as a viable clinical treatment alternative for psychiatrists to treat patients with major depressive disorder," said Chris Thatcher, President and CEO of Neuronetics, Inc. "This large subset of patients from the 66,000 patients treated worldwide provides us insights into potential new research, and for advancements in treatment protocols and patient selection."
About NeuroStar® Advanced Therapy
NeuroStar is reimbursed by most commercial and government health plans in the United States, including Medicare and Tricare. In addition, there are programs in place, such as NeuroStar Reimbursement Support, to help patients and providers obtain coverage and reimbursement for NeuroStar Advanced Therapy. Visit www.NeuroStar.com for more information about NeuroStar Advanced Therapy and click here to locate a NeuroStar doctor in the United States.
NeuroStar is also available in Japan and select other countries. NeuroStar became listed for reimbursement under Japan's national health insurance on June 1, 2019. NeuroStar is exclusively distributed in Japan by Teijin Pharma Limited.
NeuroStar is indicated in the United States for the treatment of MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. In an NIMH-funded, independent, 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).6 The most common side effect is pain or discomfort at or near the treatment site, which usually resolves within one week. It is contraindicated in people with non-removable conductive metal in or near the head.
NeuroStar® is a registered trademark of Neuronetics, Inc. (NASDAQ:STIM). For more information and full safety and prescribing information, visit www.neurostar.com.
* Response rate defined as PHQ-9 score less than 10
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SOURCE NeuroStar Advanced Therapy
Company Codes: NASDAQ-NMS:STIM