Positive Results for Deep TMS in Major Depression

Caroline Cassels

April 18, 2012

April 18, 2012 — Results from a double-blind, multicenter, controlled trial show that deep transcranial magnetic stimulation (TMS) is safe and effective in patients with major depression.

After 5 weeks of treatment, 30.4% of patients in the active treatment group achieved remission from depression, which was defined as a Hamilton Depression Rating Scale (HDRS-21) score of less than 10. In comparison, 14.5% of the sham treatment control group achieved remission (P = .0148), according to information released by Brainsway Ltd, developers of the device used in the study.

Further, the company reports there was a significant response to treatment, defined as a greater than 50% decrease from baseline HDRS-21 scores, in 36.7% of patients in the active treatment group vs 20.5% in the control group (P = .0148).

On the basis of a US Food and Drug Administration (FDA) approved clinical trial protocol, the study included 233 patients at 14 medical centers in the United States, 4 in Israel, 2 in Germany, and 1 in Canada.

All trial participants suffered from major depression and had previously failed to respond to therapeutic treatments or could not tolerate antidepressant medication owing to side effects.

Brainsway says it expects the study results will support its application for FDA approval to market its deep TMS system for the treatment of major depression in the United States.

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