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Data Published Online in The Journal of Clinical Psychiatry Show Long-Term Benefit of Non-Drug NeuroStar TMS Therapy® in Patients with Treatment Resistant Depression
Largest clinical study evaluating durability of treatment with the NeuroStar shows depression patients maintained remission through 52 weeks
MALVERN, Pa., Sept. 16, 2014 /PRNewswire/ — Neuronetics, Inc., today announced that results of a study designed to assess the long-term effectiveness of NeuroStar TMS Therapy in adult patients with Major Depressive Disorder (MDD) who have failed to benefit from prior treatment with antidepressant medications, were published online in The Journal of Clinical Psychiatry. The study found that TMS treatment with the NeuroStar TMS Therapy System induced statistically and clinically meaningful response and remission in patients with treatment resistant MDD during the acute phase of therapy, which were maintained through one year of follow-up. At the end of acute treatment, 62 percent of patients achieved symptomatic improvement while 41 percent reported complete remission. At 12 months, 68 percent of patients achieved symptomatic improvement while 45 percent reported complete remission. Maintenance of benefit was observed under a pragmatic regimen of continued antidepressant medication and TMS reintroduction for symptom recurrence.
TMS Therapy in the News: CBS Health Watch Segment
This features Dr. Alan Manevitz, presenting TMS on CBS Health Watch. Published on Apr 12, 2012
Depression is a common, but serious medical condition caused by disruptions of the brain’s chemical and electrical messaging systems. 10% of adults in the United States will suffer from a depressive episode in their lifetime. In any year, that means about 14 million will be affected.
While many effective treatments are available, including antidepressant medications and psychotherapy, almost 30% of patients will not benefit significantly. Also, many people cannot tolerate the side effects of antidepressant medication, which include sedation, jitteriness, nausea, weight gain, and sexual dysfunction.
Data Indicates Acute Transcranial Magnetic Stimulation (TMS) with TMS Therapy Improves Quality of Life in Patients with Depression
Data Published in CNS Spectrums Indicate Acute Transcranial Magnetic Stimulation (TMS) with NeuroStar TMS Therapy® Improves Quality of Life in Patients with Depression
Non-drug Treatment with NeuroStar TMS Led to Significant Symptom Improvement in Patients Not Benefitting from Prior Antidepressant Medication
MALVERN, Pa., September 16, 2013 – Neuronetics, Inc., today announced that results of a naturalistic, observational study from 42 clinical trial sites in the United States, which examined the efficacy of acute treatment with NeuroStar TMS Therapy® in patients with Major Depressive Disorder (MDD), were published in the July 2013 issue of CNS Spectrums. In the study, patients who experienced persistent symptoms of MDD without benefit from concurrent antidepressant pharmacotherapy reported statistically and clinically meaningful improvement in quality of life (QOL) symptoms and functional status following acute treatment with NeuroStar TMS Therapy. Acute efficacy results of this trial were previously reported, showing statistically significant improvement from baseline in depression symptoms including 58% response and 37% remission rates as rated by the clinician using the CGI-Severity of Illness scale under conditions of general clinical use (Carpenter, et al, 2012).
MDD is a debilitating condition in which nearly two-thirds of patients do not benefit adequately from antidepressant medications, and continue to experience life-altering symptoms and functional impairment.
“The publication of these findings is an important validation that NeuroStar TMS Therapy is effective in improving quality of life measures during acute treatment of MDD, particularly in patients with greater disease severity who have not benefitted from treatment with oral antidepressant medication,” said Philip Janicak, M.D., first author, Professor of Psychiatry at Rush University Medical Center. “Patients reported improvement in QOL outcomes after just six weeks of treatment with NeuroStar TMS, which is faster than results we typically see with pharmacotherapy. These data offer hope to people living with MDD and reinforce TMS as a viable treatment option that induces symptom relief and improves overall well-being.”
The published observational study, entitled “Transcranial Magnetic Stimulation (TMS) for Major Depression: A Multisite, Naturalistic, Observational Study of Quality of Life Outcome Measures in Clinical Practice”, involved 307 outpatients across 42 clinical TMS practice sites in the United States with a primary diagnosis of MDD who had failed to benefit from antidepressant medication. A recurrent course of illness was reported in 93 percent of patients and 44 percent had previously been hospitalized for depression. A significant level of treatment resistance was present.
At the end of the acute phase of NeuroStar TMS treatment, statistically significant improvements across physical health and mental health components variables were observed, as measured by the Short Form 36- Item Questionnaire (SF-36). Severely depressed patients experienced the most robust improvement in a relatively short time frame (six weeks). The largest treatment effects were observed on those subscale scores associated with improvements in mental health and social functioning. In addition, 37 percent (N=114) of study patients achieved remission during acute NeuroStar treatment and experienced a superior improvement in QOL compared with non-remitters. Patients with moderately severe to severe depression had the most robust improvement in QOL.
The vitality, social functioning, role-emotional, and mental health perceptions subscales of SF-36 showed a statistically significant improvement of 12-14.8 points or 1.2-1.5 standard deviations (SDs) in the normed score. The mean mental component summary (MCS) score improved by 16.8 points to 33.5 (±15.06), which is comparable to previous studies showing an improvement in the MCS scores following nine months of treatment with paroxetine (15.8), fluoxetine (15.1), or sertraline (17.4). The subpopulation of remitters showed a much more robust improvement of 27.4 to 30.9 points, reaching scores that are close to the general population norms and are only 0.13 to 0.55 SDs lower.
While the Factors Influencing Depression Endpoints Research (FINDER) Study, a European, prospective, observational trial in 3,468 patients, reported that severely depressed patients had significantly worse SF-36 MCS outcomes, the CNS Spectrums’ published study demonstrated that acute NeuroStar TMS treatment produced a pronounced QOL improvement in moderately severely- and severely-ill patients compared with the mildly- and moderately-ill groups.
About NeuroStar TMS Therapy® Neuronetics’ NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder (MDD). NeuroStar TMS Therapy is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration 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 an area of the brain that has been linked to depression by delivering highly-focused MRI-strength magnetic field pulses.
In a controlled trial, patients treated with active NeuroStar TMS Therapy received greater than 3 times the improvement in depressive symptoms compared to placebo at four weeks (MADRS,-7.1 vs-2.1,P=0.0006). The treatment is available by prescription and typically administered daily for 4-6 weeks. For full safety and prescribing information, visit www.NeuroStar.com.
Depression is a serious illness that affects about 20 million Americans annually. 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. It is estimated that about four million patients do not benefit from standard treatments for depression, even after repeated treatment attempts.
About the Study Forty-two clinical TMS practice sites across the United States treated 307 outpatients with a primary diagnosis of MDD and persistent symptoms despite adequate antidepressant pharmacotherapy. Treatment parameters were based on individual clinical considerations and followed the labeled procedures for use of the NeuroStar TMS Therapy System. Functional status was ascertained using the Medical Outcome Study Short-Form Health Survey (SF-36), comprised of eight subscales that measure physical and role functioning: bodily pain, general health, vitality, social and role functioning, and mental health. The physical component summary (PCS) score and a mental component summary (MCS) score integrate information from all eight of the subscales. Patient-reported QOL was also characterized using the EuroQol 5-Dimension Questionnaire (EQ-5D), which contains five dimensions measuring the degree of impairment in the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patient-reported outcome measures of functional status and QOL were obtained at baseline prior to the initial TMS treatment, and again at the end of acute treatment. The study is posted on www.clinicaltrials.gov, listing number NCT 01114477.
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. NeuroStar® and NeuroStar TMS Therapy® are registered trademarks of Neuronetics, Inc.
Media Contact: Sue McMonigle Neuronetics, Inc.
Office: 610-981-4153 Cell: 215-527-4205
New Data Show Long-Term Benefit of TMS in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System
New Data Show Long-Term Benefit of Transcranial Magnetic Stimulation in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System
Largest clinical study evaluating durability of Transcranial Magnetic Stimulation (TMS) shows depression patients maintained remission through 52 weeks with the NeuroStar
SAN FRANCISCO, May 21, 2013 – New data released today at the annual meeting of the American Psychiatric Association show that the NeuroStar TMS Therapy System® induced statistically and clinically meaningful response and remission in patients with Major Depressive Disorder (MDD) during the acute phase of therapy, which were maintained through one year of treatment. At the end of acute treatment, 62 percent of patients achieved symptomatic improvement while 41 percent reported complete remission. At 12 months, 68 percent of patients achieved symptomatic improvement while 45 percent reported complete remission. Maintenance of benefit was observed under a pragmatic regimen of continuation antidepressant medication and access to TMS reintroduction for symptom recurrence.“
The durability of NeuroStar TMS Therapy demonstrated by this robust, real-world study is remarkable, as it’s not typical to see long-term benefit in patients who have treatment resistant forms of depression,” said Dr. Philip Janicak, M.D., Professor of Psychiatry at Rush University, and Medical Director of the Rush Psychiatric Clinical Research Center. “The study reinforces the sustained efficacy of NeuroStar TMS Therapy in a majority of patients with depression who have not found relief through oral antidepressant medication.”
With 42 clinical practices participating, 307 patients with a primary diagnosis of unipolar, non-psychotic major depressive disorder, who had failed to receive benefit from prior antidepressant medication, received NeuroStar TMS Therapy.
The objectives of this study were to assess the change in depressive symptomatology and functional capacities across the duration of acute and long-term follow-up treatment with NeuroStar TMS. Of the patient population,257 patients received benefit with acute TMS treatment, then were tapered from their acute treatment regimen and consented to long-term observation over 52 weeks.
Clinical assessments were based on data obtained at three, six, nine and twelve months using the clinician-rated Clinical Global Impression Severity of Illness (CGI-S), and the patient-rated Patient Health Questionnaire (PHQ-9) and Inventory for Depressive Symptomatology-Self Report (IDS-SR).