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FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
Date:10/8/2008

MRI-strength magnetic pulses. Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert. It is a 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist's office. The treatment is typically administered daily for 4-6 weeks.

"In the randomized controlled trial conducted for FDA clearance, NeuroStar TMS Therapy demonstrated statistically and clinically significant treatment effects," said Phil Janicak, MD, Professor of Psychiatry at Rush University-Chicago and a Principal Investigator in the NeuroStar TMS Therapy clinical trials. "It's particularly noteworthy that these outcomes were achieved without systemic side effects, such as weight gain and sexual dysfunction."

Clinical Trials Demonstrated Efficacy and Safety of NeuroStar TMS Therapy

NeuroStar TMS Therapy was evaluated for efficacy, safety, and tolerability in the acute treatment of major depression in patients who had failed to receive benefit from prior antidepressant medications. A 6-week, randomized, placebo-controlled, double-blind, study was conducted to evaluate the safe and effective use of NeuroStar TMS as a monotherapy. An analysis for predictors of response demonstrated that the patients with the best response to NeuroStar TMS Therapy were those who had not benefited from one prior antidepressant medication at an adequate dose and duration in the current episode. These are the patients for whom NeuroStar TMS Therapy has been cleared by the FDA.

This clinical study population was comprised of 164 patients with unipolar, non-psychotic major depressive disorder. Almost all of them (97%) had suffered previous depression episodes. These patients also had an extensive treatment history without a satisfactory improvement. They had received a median of 4 total prior antidepressant treatment attempts in the current episode, one of which achieved treatment adequacy at or above the minim
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SOURCE Neuronetics, Inc.
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