Neuronetics, Inc., a privately held medical device company and developer of
the NeuroStar TMS Therapy System™ for the treatment of major depression,
recently announced results of the first multicenter, controlled clinical study
for Transcranial
magnetic stimulation (TMS) therapy. The study showed that
TMS Therapy is an effective, safe, well-tolerated treatment for patients who
have not received adequate benefit from previous antidepressant drug therapy.
The results of the trial were presented at the American Psychiatric Association
Meeting in Toronto.
NeuroStar TMS Therapy™ is currently under review by the FDA and is pending
market clearance for the treatment of major depressive disorder (MDD); its
approval is expected to come in 2006 or early 2007. The treatment is a non-invasive
outpatient method that uses highly focused, pulsed magnetic fields to stimulate
nerve cells in regions of the brain that are believed to be linked to mood
and depression. TMS Therapy requires no anesthesia or sedation, so patients
can resume normal activities immediately after the 30-40 minute treatment.
The randomized, placebo controlled clinical trial was conducted at 23 leading
research facilities throughout the US, 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
and response. All of the 301 patients involved in the trial were suffering
from major depression and had not benefited from previous therapy with antidepressants.
According to psychiatrist John O’Reardon, MD, Director of the University
of Pennsylvania’s Treatment Resistant Depression Clinic, “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.
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.” O’Reardon was a principal investigator
in the study.
© Copyright 2007 Insight Journal Online Magazine.
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Neuronetics, Inc.
New and Emerging Technologies for Treating Mood Disorders
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