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May 2008

ShareEvaluating Clinical Significance of Treatment Outcomes in Studies of Resistant Major Depression

The researchers evaluated the results of two clinical trials involving 164 patients with unipolar non-psychotic major depressive disorder who did not receive adequate benefit from one previous treatment at or above the minimal effective dose and duration. The first trial was a four-to-six week randomized, placebo-controlled, double-blind, monotherapy study of Transcranial Magnetic Stimulation (TMS). Patients who did not respond to therapy in the first study were entered into a second six-week, open-label TMS monotherapy trial. The research was conducted to assess the effectiveness of the Neuronetics NeuroStar TMS device to determine its effectiveness compared to placebo, and target when it should be introduced.

The results indicated that TMS therapy was as effective or more effective than the majority of approved pharmaceutical antidepressant treatments for either treatment-responsive or-resistant populations. Patients who failed to achieve improvement from major depressive disorder with one prior antidepressant had the most improvement from TMS treatment.

 

 

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