Department of Psychiatry and Psychotherapy, Ludwig Maximilian University Munich, Nussbaumstr. 7, 80336, Munich, Germany.
Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig Maximilian University Munich, Munich, Germany.
Eur Arch Psychiatry Clin Neurosci. 2017 Dec;267(8):751-766. doi: 10.1007/s00406-017-0769-y. Epub 2017 Feb 28.
Transcranial direct current stimulation (tDCS) has been proposed as novel treatment for major depressive disorder (MDD) based on clinical pilot studies as well as randomized controlled monocentric trials. The DepressionDC trial is a triple-blind (blinding of rater, operator and patient), randomized, placebo controlled multicenter trial investigating the efficacy and safety of prefrontal tDCS used as additive treatment in MDD patients who have not responded to selective serotonin reuptake inhibitors (SSRI). At 5 study sites, 152 patients with MDD receive a 6-weeks treatment with active tDCS (anode F3 and cathode F4, 2 mA intensity, 30 min/day) or sham tDCS add-on to a stable antidepressant medication with an SSRI. Follow-up visits are at 3 and 6 months after the last tDCS session. The primary outcome measure is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) scores at week 6 post-randomisation compared to baseline. Secondary endpoints also cover other psychopathological domains, and a comprehensive safety assessment includes measures of cognition. Patients undergo optional investigations comprising genetic testing and functional magnetic resonance imaging (fMRI) of structural and functional connectivity. The study uses also an advanced tDCS technology including standard electrode positioning and recording of technical parameters (current, impedance, voltage) in every tDCS session. Aside reporting the study protocol here, we present a novel approach for monitoring technical parameters of tDCS which will allow quality control of stimulation and further analysis of the interaction between technical parameters and clinical outcome. The DepressionDC trial will hopefully answer the important clinical question whether prefrontal tDCS is a safe and effective antidepressant intervention in patients who have not sufficiently responded to SSRIs.
ClinicalTrials.gov Identifier NCT0253016.
基于临床试点研究和随机对照单中心试验，经颅直流电刺激（tDCS）已被提议作为治疗重度抑郁症（MDD）的新方法。DepressionDC 试验是一项三盲（盲法评定者、操作者和患者）、随机、安慰剂对照的多中心试验，旨在研究前额 tDCS 作为附加治疗在未对选择性 5-羟色胺再摄取抑制剂（SSRI）有反应的 MDD 患者中的疗效和安全性。在 5 个研究地点，152 名 MDD 患者接受为期 6 周的治疗，包括使用活性 tDCS（阳极 F3 和阴极 F4，2 mA 强度，每天 30 分钟）或假刺激添加到稳定的抗抑郁药物中，SSRI 作为附加治疗。随访在最后一次 tDCS 治疗后 3 个月和 6 个月进行。主要结局测量是与基线相比，随机分组后第 6 周蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评分的变化。次要终点还涵盖其他精神病理学领域，全面的安全性评估包括认知测量。患者接受可选的检查，包括基因检测和结构和功能连接的功能磁共振成像（fMRI）。该研究还使用了一种先进的 tDCS 技术，包括标准电极定位和记录每次 tDCS 治疗中的技术参数（电流、阻抗、电压）。除了在这里报告研究方案外，我们还提出了一种监测 tDCS 技术参数的新方法，该方法将允许刺激质量控制，并进一步分析技术参数与临床结果之间的相互作用。DepressionDC 试验有望回答一个重要的临床问题，即对于未对 SSRI 有足够反应的患者，前额 tDCS 是否是一种安全有效的抗抑郁干预措施。
ClinicalTrials.gov 标识符 NCT0253016。
