Brakemeier Eva-Lotta, Wilbertz Gregor, Rodax Silke, Danker-Hopfe Heidi, Zinka Bettina, Zwanzger Peter, Grossheinrich Nicola, Várkuti Bálint, Rupprecht Rainer, Bajbouj Malek, Padberg Frank
Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
J Affect Disord. 2008 May;108(1-2):59-70. doi: 10.1016/j.jad.2007.09.007. Epub 2007 Oct 26.
Repetitive transcranial magnetic stimulation (rTMS) has been found to exert modest to moderate therapeutic effects in major depression, but mechanism of action and its clinical relevance have not been clarified yet. Previous trials have reported patterns of symptomatology predicting response to rTMS. As most patients also received concomitant antidepressant medication these response patterns may rather refer to combined treatment than rTMS alone. Thus, this study aims to replicate previous findings and explore patterns of response in drug-free patients.
In the Munich-Berlin Predictor Study data of 79 patients from two open clinical trials evaluating effects of high-frequency rTMS of the left dorsolateral prefrontal cortex were pooled. Previous models predicting the response to rTMS [Fregni, F., Marcolin, M.A., Myczkowski, M., Amiaz, R., Hasey, G., Rumi, D.O., Rosa, M., Rigonatti, S.P., Camprodon, J., Walpoth, M., Heaslip, J., Grunhaus, L., Hausmann, A., Pascual-Leone, A., 2006. Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. Int. J. Neuropsychopharmacol. 9, 641-654; Brakemeier, E.L., Luborzewski, A., Danker-Hopfe, H., Kathmann, N., Bajbouj, M., 2007. Positive predictors for antidepressive response to prefrontal repetitive transcranial magnetic stimulation (rTMS). J. Psychiatr. Res. 41, 395-403.] were systematically tested and new explorative regression analyses were conducted.
Of the 79 patients, 34.2% showed an antidepressant response. Previous models could not be validated. Explorative regression analysis revealed a significant model with therapy resistance, HAMD items 1 (depressed mood), and 2 (feelings of guilt) as negative and retardation as positive predictors.
No controlled study; specific statistical issues; sample size; differences concerning patient population and stimulation parameters between study sites.
In sum, this study does not confirm clinical valid and robust patterns being predictive for a response to rTMS in depression. The only exception is a high level of therapy resistance being associated with poor outcome. Future predictor studies should focus on large and homogenous samples of rTMS multicenter trials and include neurobiological variables.
重复经颅磁刺激(rTMS)已被发现对重度抑郁症有一定程度的治疗效果,但其作用机制及其临床相关性尚未明确。先前的试验报告了预测rTMS反应的症状模式。由于大多数患者同时还接受了抗抑郁药物治疗,这些反应模式可能更多地指联合治疗而非单纯的rTMS治疗。因此,本研究旨在重复先前的发现,并探索未服用药物患者的反应模式。
在慕尼黑 - 柏林预测研究中,汇总了来自两项评估左侧背外侧前额叶皮质高频rTMS效果的开放临床试验的79例患者的数据。对先前预测rTMS反应的模型[Fregni, F., Marcolin, M.A., Myczkowski, M., Amiaz, R., Hasey, G., Rumi, D.O., Rosa, M., Rigonatti, S.P., Camprodon, J., Walpoth, M., Heaslip, J., Grunhaus, L., Hausmann, A., Pascual - Leone, A., 2006. Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. Int. J. Neuropsychopharmacol. 9, 641 - 654; Brakemeier, E.L., Luborzewski, A., Danker - Hopfe, H., Kathmann, N., Bajbouj, M., 2007. Positive predictors for antidepressive response to prefrontal repetitive transcranial magnetic stimulation (rTMS). J. Psychiatr. Res. 41, 395 - 403.]进行了系统测试,并进行了新的探索性回归分析。
79例患者中,34.2%显示出抗抑郁反应。先前的模型未能得到验证。探索性回归分析显示,一个显著的模型包含治疗抵抗、汉密尔顿抑郁量表(HAMD)第1项(情绪低落)和第2项(内疚感)为负向预测因子,迟缓为正向预测因子。
无对照研究;存在特定的统计问题;样本量;研究地点之间患者群体和刺激参数的差异。
总之,本研究未证实存在对抑郁症rTMS反应具有预测性的临床有效且可靠的模式。唯一的例外是高治疗抵抗水平与不良预后相关。未来的预测研究应聚焦于rTMS多中心试验的大样本且同质的样本,并纳入神经生物学变量。