New data released today at the annual meeting of the American Psychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy@ achieved significant improvements in both depression symptoms and in quality of life measurements. Overall, 58 percent of patients achieved a positive response to NeuroStar TMS therapy, with 37 percent of patients achieving remission from their depression.
(Logo: http://photos.prnewswire.com/prnh/20120508/PH01517LOGO ) After an average of five weeks of NeuroStar treatment, the percentage of patients reporting extreme problems with anxiety and depression decreased by 42.2 percent, demonstrating a reduction in depression symptomatology. For overall treatment effect, the percentage of patients reporting no problems in performing usual activities improved by 30.5 percent.
"The improvements we observed show that non-drug therapy with NeuroStar TMS not only reduces the symptomatic suffering of patients, but lessens the disability of depression with important implications for these individuals' ability to return to functioning effectively at home, in the workplace, and in the community," said Ian A. Cook, M.D., Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles.
In the open label study, which involved 307 patients receiving acute treatment with NeuroStar TMS, patients experienced statistically-significant improvement across physical and mental variables as measured by the Short Form 36-Item Questionnaire (SF-36). The SF-36 is a multi-purpose, short-form health survey that evaluates functional health and well-being of disease among eight variables including physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. After five weeks of acute TMS therapy, the most drastic improvement was seen in the mental component summary score, which more than doubled from 16.6 prior to therapy to 33.5 after therapy.
Similarly, self-reported quality of life measures significantly improved with TMS therapy compared to baseline according to the EuroQol Questionnaire (EQ-5D), a standardized instrument that was used to evaluate the effect of TMS therapy on the quality of life of patients. At the end of acute treatment with TMS, the greatest improvements in EQ-5D dimensions were observed among patients who indicated no problems with "usual activities" (14.3 percent pre-TMS vs. 44.8 percent post-TMS), "anxiety/depression" (1.6 percent pre-TMS vs. 30.1 percent post-TMS) and "pain/discomfort" (39.4 percent pre-TMS vs. 52.8 percent post-TMS). In other EQ-5D dimensions, 81.8 percent of patients reported no problems with "mobility" following TMS treatment vs. 68.7 percent at baseline; 87.1 percent of patients reported no problems with "self-care" following TMS treatment vs. 72.6 percent at baseline.
"These data reinforce the clinical efficacy of TMS Therapy as a viable option for patients living with major depression who have not achieved or maintained symptom improvement with oral antidepressants," said H.
Brent Solvason, M.D., Stanford University Medical Center. "The most meaningful takeaway for patients is that TMS Therapy has the potential to make them feel better, in addition to potentially allowing them to experience a level of physical and social functionality they haven't had with their depression." About Transcranial Magnetic Stimulation TMS is a non-invasive, non-systemic therapeutic device that delivers magnetic resonance imaging (MRI)-strength, pulsed, magnetic fields to induce an electronic current in a localized region of the cerebral cortex, the part of the brain that controls mood. NeuroStar TMS Therapy is the first and only TMS therapy for major depressive disorder cleared by the U.S. Food and Drug Administration (FDA) that has been proven to achieve remission without systemic side effects in patients who have not found relief with antidepressant medication.
About Depression 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 The clinical trial was a multi-site, naturalistic, observational study involving 307 patients receiving acute treatment with TMS therapy across 43 clinical practices. All treatments were initiated using the NeuroStar TMS Therapy@ System (Neuronetics, Inc., Malvern, PA, USA). The study is posted on www.clinicaltrials.gov, listing number NCT 01114477.
About NeuroStar TMS Therapy @ Neuronetics' NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of MDD. NeuroStar TMS Therapy is indicated for the treatment of Major Depressive Disorder 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. The treatment is typically administered daily for 4-6 weeks. For full safety and prescribing information, visit www.NeuroStar.com.
About Neuronetics 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. Neuronetics was created as a spin-out of The Innovation Factory, a medical device incubator in Duluth, GA. For more information, please visit www.neuronetics.com.
NeuroStar@, NeuroStar TMS Therapy@ and TMS Therapy@ are registered trademarks of Neuronetics, Inc.
SOURCE Neuronetics, Inc.
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