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Neurostar data suggest new option for depression therapy
MALVERN, Pa.—Neuronetics, Inc. has reported that clinical data from its NeuroStar Outcomes Registry — which suggests that NeuroStar Advanced Therapy should 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. The article is currently available online.
“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 NeuroStar Outcomes Registry was 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. Since its launch, it has reportedly grown into the largest registry focused on outcomes for depression treatment.
The NeuroStar system is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation (TMS) to create a pulsed, MRI-strength magnetic field. This field induces electrical currents designed to stimulate specific areas of the brain which are associated with mood.
The study authors found that treatment with NeuroStar showed robust antidepressant effects, greater than in early open-label studies of TMS. The clinical benefit from NeuroStar reported by both patients and clinicians in routine clinical practice compared favorably with alternative interventions for treatment-resistant depression. Strong efficacy, as well as a low side effect and medical risk profile, suggests that NeuroStar therapy should be evaluated as a first-line treatment for major depressive disorder.
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 Clinical Global Impression – Severity (CGI-S) scale.
“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,” Sackeim added.
Remission rates were notably high (27.9 to 57.8 percent) in both the study’s intent-to-treat sample (n=5010) and the completer sample (n=3814). And response rates were notably high across both self-report and clinician-administered assessments in the completer sample.
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, and females responded more favorably to treatment than males by 5 to 10 percent.
Noted Keith J. Sullivan, president and CEO of Neuronetics, “this promising data from the Outcomes Registry underscores the importance of innovative and effective depression treatments like NeuroStar. 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.”