New Investigational Procedure to Treat Major Depression Being Tested in Global University Medical and Clinical Research Centers Twenty Sites Conduct Clinical Research Trials On Investigational, Non-

Medication Approach to Treat Depression



    MALVERN, Pa., April 27 /PRNewswire/ -- Transcranial Magnetic Stimulation
 (TMS), an investigational noninvasive technique that uses repeated short
 bursts of magnetic energy to stimulate nerve cells in the brain, has been
 studied in numerous small clinical research trials.  The results from these
 trials have encouraged researchers that TMS may produce an antidepressant
 effect.  TMS is now being tested at 20 university medical centers and clinical
 research centers as a potential future treatment for patients with major
 depression.
     "The ongoing clinical trial will include approximately 300 individuals at
 20 centers," said Bruce Shook, president of Neuronetics, Inc., the company
 that developed the TMS device.  "More than half of the required study
 participants have now been enrolled.  The study is moving along rapidly and
 will be completed this year."
     Typical ways of treating depression include antidepressants and other
 medications; electroconvulsive therapy (ECT); and psychotherapy.  This study
 focuses on people who either have failed to benefit from antidepressant
 medications or have been unable to tolerate the adverse effects of
 antidepressant medications.
 
     Regulatory Clearance Sought
     The clinical trial currently underway is a large, rigorous, controlled
 trial designed to provide data in support of a regulatory application to the
 U.S. Food and Drug Administration for marketing clearance of the Neuronetics
 TMS System for the treatment of depression.
     "If it is proven effective, TMS would be an innovative and non-invasive
 therapeutic option, especially for people who haven't benefited from other
 therapies," said Shook.  "We anticipate seeking FDA approval in 2006."
     Trial sites currently enrolling study participants are located in Dallas
 and Houston, TX; St. Louis, MO; Chicago, IL; Durham and Winston Salem, NC; Ann
 Arbor, MI; Philadelphia, PA; Palo Alto and San Diego, CA and Charlottesville,
 VA.  Individuals in these areas who believe they may qualify for the study can
 visit the Neuronetics website, http://www.neuronetics.com or call 800-345-8707
 for more information, Shook said.
 
     Noninvasive Technique
     Researchers believe the left prefrontal cortex is one of the critical
 components of the brain circuitry involved in regulating mood.  Transcranial
 magnetic stimulation (TMS) produces pulses of magnetic energy that are
 directly targeted at this part of the brain with the goal of improving the
 function of these key brain pathways.
     The TMS technology creates a high intensity magnetic field with
 characteristics similar to those produced by standard MRI machines.  However,
 instead of helping doctors look inside the body to diagnose disease, the
 pulses of magnetic energy produce a stimulus in the brain that researchers
 believe causes positive changes in mood.  The amount of energy delivered to
 the brain is very small and very focused.  Study participants remain fully
 awake during the 45-minute outpatient procedure and can go about their normal
 activity before and after the procedure.  TMS is performed without anesthesia
 or sedation, and it does not cause memory loss, as can occur with ECT, or the
 side effects common with oral antidepressants.
 
     Major Depression - An Unmet Medical Need
     The National Institute of Mental Health reports that depression affects
 more than 18 million adults every year.  Even with recent advances in
 antidepressant medications, a significant percentage of patients experience
 treatment-resistant or recurrent episodes of depression.  Some patients cannot
 tolerate medications.
     This nationwide research study is a pivotal trial.  If the results of the
 study are positive and if the U.S. FDA clears the TMS technology for
 marketing, an entirely new treatment option for patients suffering from
 depression would be available for the future.
 
     Who Is Eligible?
     Individuals who believe they may qualify for the study are urged to visit
 the Neuronetics website, http://www.neuronetics.com, or call 800-345-8707 to
 locate a research center near their home.  To qualify, patients must:
     -- Be between 18 and 70 years old.
     -- Be suffering from a major depressive disorder.
     -- Be able to provide written documentation that they have been
        unsuccessfully treated previously with antidepressant medication.
 
     Patients who have been diagnosed with bipolar illness (manic depression)
 or obsessive-compulsive disorder are not eligible to participate in the trial.
 
     Trial sponsor:  Neuronetics, Inc., is a medical device company that is
 focused on developing non-invasive therapies for psychiatric and neurological
 disorders using pulsed magnetic fields.  For more information on Neuronetics:
 http://www.neuronetics.com; info@neuronetics.com; 610-640-4202, ext. 1015.
 
 

SOURCE Neuronetics, Inc.

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