Posted by ttee on May 23, 2006, at 20:34:51
In reply to rtms, posted by Larry C on April 24, 2006, at 5:47:10
FOR IMMEDIATE RELEASE
NEURONETICS ANNOUNCES POSITIVE MULTICENTER CLINICAL TRIAL RESULTS WITH TMS THERAPY™ FOR TREATING DEPRESSION
Drug-free, non-invasive treatment could benefit millions
TORONTO, CANADA – May 23, 2006 – Neuronetics, Inc., a privately held medical device company and developer of the NeuroStar TMS Therapy SystemTM for the treatment of major depression, today announced results of the first multicenter, controlled clinical trial for transcranial magnetic stimulation (TMS) therapy. The study demonstrated that TMS Therapy™ is an effective, safe, well tolerated antidepressant for patients who have not received adequate benefit from previous antidepressant medications. The trial results were presented at the American Psychiatric Association Meeting in Toronto, Canada.
NeuroStar TMS Therapy™, which is currently under review by the FDA and is pending market clearance for the treatment of major depression, is a non-invasive, outpatient treatment. It uses highly focused, pulsed magnetic fields to stimulate nerve cells in brain regions believed to be linked to depression. TMS Therapy does not require anesthesia or sedation, so patients can resume normal activities immediately after the 40-minute treatment.
The randomized, sham-controlled clinical trial was conducted at 23 leading clinical research institutions throughout the U.S., Canada and Australia to test the acute efficacy and safety of NeuroStar TMS Therapy. Extension studies provided open-label treatment for non-responders and a 6-month observation period for maintenance of response. All 301 patients who participated were suffering from major depression and had not benefited from previous antidepressant medication therapy.
“TMS Therapy offers patients with resistant depression a non-invasive, drug-free treatment alternative. In the randomized, controlled trial, TMS-treated patients had significantly higher response and remission rates than sham-treated patients,” said psychiatrist John O’Reardon, M.D., Director of the University of Pennsylvania’s
Treatment Resistant Depression Clinic and a principal investigator of the trial. “Additionally, TMS Therapy was remarkably well tolerated with less than 8% of patients leaving the study during the acute treatment trial. It clearly provides new hope for depressed patients.”
“Approximately 1 in 2 patients improved with TMS Therapy in the open-label study, despite being resistant to previous drug treatment,” said Alan Schatzberg, M.D, Chair of Stanford University’s Department of Psychiatry. “This is important because this study most closely mimics the real-world clinical practice setting. “
While not yet complete, the preliminary results from the 6-month observation study suggest that most of the patients maintained their response using simple single-medication treatment without the need for additional TMS Therapy.
"Depression afflicts approximately 14 million Americans annually” said Neuronetics President and CEO, Bruce Shook. “Unfortunately, drugs don’t help everyone and fail to achieve an adequate response in more than one-third of all depressed patients. Plus, they often cause side effects such as sedation, weight gain, sexual dysfunction, and gastrointestinal distress. If cleared by the FDA, NeuroStar TMS Therapy could help a significant number of patients without the burden of systemic side effects, opening new avenues for treating this widespread disease.”
The most common adverse event reported was headache. Slightly more than half of the patients receiving sham treatment or active treatment reported headaches. The incidence of headaches was generally mild to moderate and declined after the first week of treatment.
In addition to Stanford University and the University of Pennsylvania, research sites included Mayo Clinic, Columbia University, University of Washington, University of Texas, Baylor College of Medicine, Washington University, Rush Presbyterian, Northwestern University, University of Michigan, Wake Forest, Emory University, Duke University, University of Virginia, Medical University of South Carolina, Psycare, Inc., Sheppard Pratt Health System, Radiant Research, Centre for Addiction and Mental Health in Canada, and Black Dog Institute and Alfred Psychiatric Research Centre in Australia.
About Depression
Major depression is a serious medical illness affecting more than 14 million Americans annually. More than 4 million patients with major depression are resistant or intolerant to currently available treatments. Unlike normal temporary emotional states of sadness from external events like a loss or other negative events, major depression is persistent and can significantly interfere with an individual's thoughts, behavior, mood, and physical health. Mental illness is the leading cause of disability in the U.S. and depression is the most predominant illness within the mental health arena.
Women are almost twice as likely as men to suffer from depression. However, some experts feel that depression in men is significantly under-reported. Major depression can occur at any age, including childhood, the teenage years and adulthood. Major depression has no racial, ethnic, or socioeconomic boundaries. About two-thirds of those who experience an episode of depression will have at least one other episode in their lives. It is not unusual for depression sufferers to have more than one episode in any given year.
About Neuronetics, Inc.
Neuronetics, Inc. is a privately held medical device company focused on developing therapies for psychiatric and neurological disorders using the energy in magnetic fields. Based in Malvern, PA., Neuronetics is the leader in the development of TMS Therapy, a completely non-invasive form of neuromodulation. For more information, visit www.neuronetics.com.
NeuroStar TMS Therapy SystemTM is pending FDA clearance for the treatment of Major Depressive Disorder and is not commercially available. It is an investigational device and limited by federal law to investigational use.
NeuroStar TMS Therapy System, NeuroStar TMS Therapy, and TMS Therapy are trademarks of Neuronetics, Inc.
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