Neuronetics, a Malvern, Pennsylvania company, has won FDA’s first approval for a transcranial magnetic stimulation (TMS) system for treatment of depression in patients that don’t respond to drug therapy. This is a huge step for a technology we’ve been following for many years now. Deep TMS devices are thought not only to help with depression, but one day might be indicated for schizophrenia, migranes, and restoration of peripheral vision for patients who are status post stroke.
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 4 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 non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation which stimulates nerve cells in an area of the brain that is linked to depression, by delivering highly focused 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.
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, study1 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 episode2. These are the patients for whom NeuroStar TMS Therapy has been cleared by the FDA.
This clinical study population2 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 minimal effective dose and duration. Forty-eight percent were unemployed due to their depression, 35% had a co-morbid anxiety disorder, and all had moderate to severe depressive symptoms.
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, study1 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 episode2. These are the patients for whom NeuroStar TMS Therapy has been cleared by the FDA.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 4 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) 3. NeuroStar TMS Therapy-treated patients had statistically significant response3 and remission4 rates, which were approximately twice the rate of placebo-treated patients. The response rate is the percentage of patients who had a >50% improvement in symptoms, and the remission rate is the percentage of patients who achieved virtually complete symptom resolution. NeuroStar TMS Therapy also produced statistically significant improvements on the HAMD factor scores for core depression symptoms, anxiety symptoms, somatization, and psychomotor retardation.4
Press release: FDA Clears NeuroStar® TMS Therapy for the Treatment of Depression, October 8, 2008 (PDF)
Product page: NeuroStar TMS Therapy System
Flashbacks: FDA to Consider Transcranial Magnetic Stimulation System , Deep TMS Technology by Brainsway, Transforming the Psychiatrist’s Office, and many other posts under Medgadget’s transcranial magnetic stimulation archive…