A double-blind sham controlled trial of rTMS in treatment resistant major depression

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Treatment Resistant Depression is clearly a major health issue - depression is common, results in marked morbidity and mortality and a large percentage of patients do not respond to, or cannot tolerate standard treatment. The development of new treatments for this condition is undoubtedly required. International efforts are underway to try and establish the efficacy of high frequency left Transcranial Magnetic Stimulation (HFL-TMS) to the point where the technique may be approved by regulatory authorities and clinically introduced. However, clearly the response rate to HFL-TMS is suboptimal for its widespread use. The overall goal of this research program is to develop repetitive TMS (rTMS) methods to the point at which they are highly relevant and applicable to clinical practice. None of the substantial international studies is focusing on novel applications such as sequential bilateral rTMS (SBrTMS). The planned outcome of this study is that it may change the focus of rTMS application and practice nationally and internationally. If we can follow our well received initial study of this technique with a substantial comparative trial as planned here, it will provide enough evidence for the more widespread adoption and testing of SBrTMS as a viable alternative to HFL-TMS. Ultimately, this or a modification of it, may become the rTMS administration method of choice. Additionally, we will have a sufficient sample size to start to explore meaningful predictors of clinical response including biological, psychosocial-personality variable predictors.