FDA Okays Transcranial Magnetic Stimulation to Treat Depression
By Peggy Peck ROCKVILLE, Md., 20 oct 2008-- The FDA has approved a transcranial magnetic stimulation system (NeuroStar TMS) for treatment of major depressive disorder in adult patients for whom traditional therapies have failed. The device delivers focused, MRI-strength magnetic pulses to the brain. The procedure, typically administered daily for four to six weeks, takes about 40 minutes and is done on an outpatient basis. In a six-week, randomized, placebo-controlled trial of 164 patients with unipolar, non-psychotic, major depressive disorder the device was associated with a statistically significant improvement in symptoms (P
<0.0006) compared with controls. All of the patients in the study had failed to find relief with at least one prior depression therapy. Compared with patients treated with a sham device, twice as many patients treated with the active device had an improvement of at least 50% in symptoms. They also achieved statistically significant improvements on the Hamilton Depression Rating scale measurements of factor scores for core depression symptoms, anxiety symptoms, somatization, and psychomotor retardation. Patients had none of the systemic side effects often reported in depression therapy trials, such as weight gain, sexual dysfunction, sedation, nausea, or dry mouth. There were no reported adverse effects on concentration or memory, and no seizures. The most common device-related adverse event was scalp pain or discomfort at the treatment area during active treatment, but this effect declined after the first week of treatment. The FDA said the device was contraindicated in patients with implanted metallic devices or non-removable metallic objects in or around the head. Moreover, the stimulator has not been studied as a first-line treatment and its efficacy has not been established in patients who failed to achieve benefit from antidepressant therapy when the drugs were dosed at levels less than minimal effective dose or duration. The device maker, Neuronetics of Malvern, Pa., said that initially NeuroStar TMS Therapy "will only be available in a limited number of treatment centers around the country."