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Real-world data from more than five thousand patients included in Neuronetics’ NeuroStar Outcomes Registry
MALVERN, Pa., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders, announced today that clinical data from its NeuroStar Outcomes Registry, which suggests NeuroStar Advanced Therapy be evaluated as a first-line treatment for Major Depressive Disorder (MDD), will be published in the December 2020 print issue of the Journal of Affective Disorders and is available online now.
The NeuroStar Outcomes Registry launched in November 2016 for the purpose of collecting and analyzing outcomes data from treatment in real-world clinical settings with Neuronetics’ NeuroStar Advanced Therapy, a non-drug, non-invasive option for treating depression. Since its launch, it has grown into the largest registry focused on outcomes for depression treatment.
The study authors found that treatment with NeuroStar Advanced Therapy showed robust antidepressant effects, greater than in early open-label studies of transcranial magnetic stimulation (TMS). The clinical benefit from NeuroStar Advanced Therapy reported by both patients and clinicians in routine clinical practice compared favorably with alternative interventions for treatment-resistant depression. The authors analyzed two sample sets of more than 5,000 patients across 103 practice sites, evaluating patient-rated and clinician-rated clinical outcomes data from treatment with NeuroStar. The research further validates efficacy results shown in a prior naturalistic study, which showed a 58 percent response rate and 37 percent remission rate on the CGI-S scale.1
“Research from the Outcomes Registry continues to demonstrate that NeuroStar Advanced Therapy is a safe and effective treatment for those with depression who haven’t benefited from antidepressant medications, and we’re excited by the opportunity to share this research published in the Journal of Affective Disorders with the broader clinical community,” said Dr. Harold A. Sackeim, Professor of Clinical Psychology in Psychiatry and Radiology at the Vagelos College of Physicians and Surgeons, Columbia University and lead author of the study. “The research demonstrates that NeuroStar Advanced Therapy can transform lives of many patients struggling with treatment-resistant depression and provides physicians with the scientific evidence needed to optimize the treatment of patients with depression.”
Study highlights include:
Self-reported and clinician ratings showed robust antidepressant effects from NeuroStar Advanced Therapy, greater than those in early open-label studies of TMS
Strong efficacy and the low side effect and medical risk profile suggest that NeuroStar Advanced Therapy be evaluated as a first-line treatment for Major Depressive Disorder
Efficacy did not decline with age, and motor threshold was also unrelated to antidepressant effects
Patients who received a larger number of pulses per session had superior outcomes
Females responded more favorably to treatment than males by 5-10%
Remission rates were notably high (27.9% to 57.8%) in both the Intent-to-Treat sample (N=5010) and the Completer sample (N=3814)
Response rates were notably high across self-report and clinician-administered assessments in the Completer sample (N-3,814)
“At a time when many are struggling with depression and facing the unprecedented challenges of the COVID-19 pandemic, this promising data from the Outcomes Registry underscores the importance of innovative and effective depression treatments like NeuroStar,” said Keith J. Sullivan, President and CEO of Neuronetics. “It is incredible to see how far the Outcomes Registry has progressed, not only providing real-world insights and best practices that advance the treatment of MDD, but also staying true to our mission of renewing lives by transforming neurohealth.”
The Journal of Affective Disorders is a peer-reviewed medical journal of the International Society for Affective Disorders that publishes papers and cutting-edge research on multiple aspects of affective disorders, including biochemistry, pharmacology, genetics, statistics, clinical studies, and studies of treatments. The Outcomes Registry publication is available online here and will be published in the December 2020 print edition, Volume 277 of the Journal of Affective Disorders.
Neuronetics, Inc. is a commercial-stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from psychiatric disorders. Its commercial product, the NeuroStar® Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation, or TMS, to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood. The system is cleared by the United States Food and Drug Administration, or FDA, for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar is also available in other parts of the world, including Japan, where it is listed under Japan’s national health insurance. Additional information can be found at www.neuronetics.com.
1 Carpenter LL, et al. Depress Anxiety, (2012)