Psychiatry - November 2008 - (Page 14)

Psych Rx FDA CLEARS NEUROSTAR® TMS THERAPY FOR THE TREATMENT OF DEPRESSION Malvern, PA—Neuronetics, Inc. announced recently that the US Food and Drug Administration (FDA) has cleared its NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system for the treatment of depression. NeuroStar TMS Therapy® is specifically 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. In clinical trials with NeuroStar TMS Therapy, these patients had been treated with a median of four medication treatment attempts, one of which achieved criteria for adequate dose and duration. The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared by the FDA for the treatment of depression. TMS Therapy is a nonsystemic and noninvasive form of neuromodulation that stimulates nerve cells in an area of the brain that is linked to depression by delivering highly focused magnetic resonance image (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 toi 6 weeks. 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 six14 Psychiatry 2008 [NOVEMBER] 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 comprised 164 patients with unipolar, nonpsychotic, major depressive disorder. Most of them (97%) had suffered previous depression episodes. These patients also had extensive treatment histories without satisfactory improvement. They had received a median of four total prior antidepressant treatment attempts in the current episode, one of which achieved treatment adequacy at or above the minimal effective dose and duration. Forty-eight percent were unemployed due to their depression, 35 percent had a comorbid anxiety disorder, and all had moderate to severe depressive symptoms. In the indicated patient population, the following efficacy results were observed in the randomized, controlled study: • The primary efficacy measure, the Montgomery-Asberg Depression Rating Scale (MADRS) symptom score change at four weeks, was statistically significantly superior to placebo (p=0.0006), among NeuroStar-treated patients. Similar results were observed with the Hamilton Depression Rating Scale (HAMD). • NeuroStar TMS Therapy-treated patients had statistically significant response and remission rates, which were approximately twice the rate of placebo-treated patients. • NeuroStar TMS Therapy produced statistically significant improvements on the HAMD factor scores for core depression symptoms, anxiety symptoms, somatization, and psychomotor retardation. The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment. There was a less than five percent discontinuation rate due to adverse events. During a 6month follow-up period, there were no new safety observations compared to those seen during acute treatment. NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices or nonremovable metallic objects in or around the head. As with any antidepressant treatment, patients should be monitored for symptoms of worsening depression. NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment. Efficacy has not been established in patients who have failed to receive benefit from two or more prior antidepressant treatments at minimal effective dose and duration in the current episode. Initially, NeuroStar TMS Therapy will only be available in a limited number of treatment centers around the country. For specific information on treatment locations with NeuroStar TMS Therapy, please visit www.NeuroStarTMS.com . http://www.NeuroStarTMS.com

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Psychiatry - November 2008 Editor's Message Editorial Advisory Board Contents PsychRx Letters to the Editor Measuring Adverse Events in Psychiatry Nonsuicidal Self Injury in Adolescents Relative Tolerability of Alzheimer's Disease Treatments Biracial Identity Development and Recommendations in Therapy Depression and Cardiovascular Disease: Just an Urban Legend? Three Risk Management Basics Journal Watch Classified Advertising Information for Authors

Psychiatry - November 2008

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