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

rTMS 治疗难治性重度抑郁症的双盲假对照试验

• 批准号: nhmrc : 436710
• 负责人: Prof Jayashri Kulkarni
• 金额: $ 24.77万
• 依托单位: Monash University
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2007
• 资助国家: 澳大利亚
• 起止时间: 2007-01-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/double-blind-sham-major-depression/98488
• 关键词: double; blind; sham; controlled; trial

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.

难治性抑郁症显然是一个主要的健康问题-抑郁症是常见的，导致显着的发病率和死亡率，很大比例的患者不响应，或不能耐受标准治疗。毫无疑问，需要为这种情况开发新的治疗方法。国际上正在努力尝试和建立高频左经颅磁刺激（HFL-TMS）的有效性，以使该技术可以获得监管机构的批准并在临床上引入。然而，很明显，HFL-TMS的反应率对于其广泛使用来说是次优的。该研究项目的总体目标是开发重复性TMS（rTMS）方法，使其高度相关并适用于临床实践。没有实质性的国际研究集中在新的应用，如顺序双边rTMS（SBrTMS）。这项研究的计划结果是，它可能会改变国内和国际上rTMS应用和实践的重点。如果我们能够按照我们的计划进行大量的比较试验，遵循我们对这项技术的初步研究，它将为更广泛地采用和测试SBrTMS作为HFL-TMS的可行替代方案提供足够的证据。最终，这种或其修改可能成为rTMS管理方法的选择。此外，我们将有足够的样本量来开始探索临床反应的有意义的预测因素，包括生物学、心理社会-人格变量预测因素。