Clinical Data on Transcranial Magnetic Stimulation for the Treatment of Depression
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 six-week, randomized, placebo-controlled, double-blind study was conducted to evaluate the use of TMS as a monotherapy. An analysis for predictors of response demonstrated that the patients with the best response to TMS therapy were those who had not benefited from one prior antidepressant medication at an adequate dose and duration in the current depressive episode.
This clinical study population was comprised of 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 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. Thirty-five percent of the patients had a co-morbid 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 significant compared to placebo (p=0.0006), for TMS-treated patients. Similar results were observed with the Hamilton Depression Rating Scale (HAMD).
TMS therapy-treated patients had statistically significant response and remission rates, which were approximately twice the rate of placebo-treated patients.
In an open-label clinical trial, which is most like real-world practice, 1 in 2 patients suffering from depression improved significantly, and 1 in 3 patients were completely free of depression symptoms after six weeks of treatment.