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Abstract：
UNASSIGNED: Bipolar mania is a common disabling illness. Electroconvulsive therapy (ECT) is an effective treatment for patients with severe mania, though it is limited by the risk of cognitive adverse effects. Magnetic seizure therapy (MST) as an alternative treatment to ECT for bipolar mania has not yet been reported.
UNASSIGNED: To compare the effectiveness and cognitive adverse effects of MST and ECT in bipolar mania.
UNASSIGNED: This randomized clinical trial was conducted at the Shanghai Mental Health Center from July 1, 2017, through April 26, 2021. Forty-eight patients with bipolar mania were recruited and randomly allocated to receive MST or ECT. The data analysis was performed from June 5, 2021, through August 30, 2023.
UNASSIGNED: Patients completed 2 or 3 sessions of MST or ECT per week for a total of 8 to 10 sessions. The MST was delivered at 100% device output with a frequency of 75 Hz over the vertex.
UNASSIGNED: The primary outcomes were reduction of total Young Manic Rating Scale (YMRS) score and response rate (more than 50% reduction of the total YMRS score compared with baseline). An intention-to-treat (ITT) analysis and repeated-measures analyses of variance were conducted for the primary outcomes.
UNASSIGNED: Twenty patients in the ECT group (mean [SD] age, 31.6 [8.6] years; 12 male [60.0%]) and 22 patients in the MST group (mean [SD] age, 34.8 [9.8] years; 15 male [68.2%]) were included in the ITT analysis. The response rates were 95.0% (95% CI, 85.4%-100%) in the ECT group and 86.4% (95% CI, 72.1%-100%) in the MST group. The YMRS reduction rate (z = -0.82; 95% CI, -0.05 to 0.10; P = .41) and response rate (χ2 = 0.18; 95% CI, -0.13 to 0.31; P = .67) were not significantly different between the groups. The time-by-group interaction was significant for the language domain (F1,24 = 7.17; P = .01), which was well preserved in patients receiving MST but worsened in patients receiving ECT. No serious adverse effects were reported in either group.
UNASSIGNED: These findings suggest that MST is associated with a high response rate and fewer cognitive impairments in bipolar mania and that it might be an alternative therapy for the treatment of bipolar mania.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03160664.
UNASSIGNED: To compare the effectiveness and cognitive adverse effects of MST and ECT in bipolar mania.
UNASSIGNED: This randomized clinical trial was conducted at the Shanghai Mental Health Center from July 1, 2017, through April 26, 2021. Forty-eight patients with bipolar mania were recruited and randomly allocated to receive MST or ECT. The data analysis was performed from June 5, 2021, through August 30, 2023.
UNASSIGNED: Patients completed 2 or 3 sessions of MST or ECT per week for a total of 8 to 10 sessions. The MST was delivered at 100% device output with a frequency of 75 Hz over the vertex.
UNASSIGNED: The primary outcomes were reduction of total Young Manic Rating Scale (YMRS) score and response rate (more than 50% reduction of the total YMRS score compared with baseline). An intention-to-treat (ITT) analysis and repeated-measures analyses of variance were conducted for the primary outcomes.
UNASSIGNED: Twenty patients in the ECT group (mean [SD] age, 31.6 [8.6] years; 12 male [60.0%]) and 22 patients in the MST group (mean [SD] age, 34.8 [9.8] years; 15 male [68.2%]) were included in the ITT analysis. The response rates were 95.0% (95% CI, 85.4%-100%) in the ECT group and 86.4% (95% CI, 72.1%-100%) in the MST group. The YMRS reduction rate (z = -0.82; 95% CI, -0.05 to 0.10; P = .41) and response rate (χ2 = 0.18; 95% CI, -0.13 to 0.31; P = .67) were not significantly different between the groups. The time-by-group interaction was significant for the language domain (F1,24 = 7.17; P = .01), which was well preserved in patients receiving MST but worsened in patients receiving ECT. No serious adverse effects were reported in either group.
UNASSIGNED: These findings suggest that MST is associated with a high response rate and fewer cognitive impairments in bipolar mania and that it might be an alternative therapy for the treatment of bipolar mania.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03160664.
摘要：
■双相躁狂症是一种常见的致残性疾病。电惊厥治疗(ECT)是治疗严重躁狂症的有效方法,尽管它受到认知不良影响风险的限制。尚未报道磁性癫痫发作疗法（MST）作为ECT治疗双相躁狂的替代疗法。
■比较MST和ECT在双相躁狂中的有效性和认知不良反应。
■这项随机临床试验于2017年7月1日至2021年4月26日在上海精神卫生中心进行。招募了48例躁郁症躁狂症患者，并随机分配接受MST或ECT。数据分析从2021年6月5日至2023年8月30日进行。
■患者每周完成2或3次MST或ECT，共8至10次。MST在100%装置输出下在顶点上以75Hz的频率递送。
■主要结果是青年躁狂量表（YMRS）总评分和缓解率降低（与基线相比，YMRS总评分降低50%以上）。对主要结局进行了意向治疗（ITT）分析和重复测量方差分析。
■ECT组20名患者（平均[SD]年龄，31.6[8.6]岁；12名男性[60.0%]）和MST组22名患者（平均[SD]年龄，34.8[9.8]岁；15名男性[68.2%]）被纳入ITT分析。ECT组为95.0%(95%CI,85.4%-100%),MST组为86.4%(95%CI,72.1%-100%)。两组间YMRS降低率（z=-0.82；95%CI，-0.05~0.10；P=0.41）和有效率（χ2=0.18；95%CI，-0.13~0.31；P=0.67）无显著差异。按时间分组的交互在语言领域是显著的(F1,24=7.17;P=0.01)，在接受MST的患者中保存完好，但在接受ECT的患者中恶化。两组均无严重不良反应报告。
■这些研究结果表明，MST与双相躁狂症的高反应率和较少的认知障碍相关，它可能是双相躁狂症的替代疗法。
■ClinicalTrials.gov标识符：NCT03160664。
■比较MST和ECT在双相躁狂中的有效性和认知不良反应。
■这项随机临床试验于2017年7月1日至2021年4月26日在上海精神卫生中心进行。招募了48例躁郁症躁狂症患者，并随机分配接受MST或ECT。数据分析从2021年6月5日至2023年8月30日进行。
■患者每周完成2或3次MST或ECT，共8至10次。MST在100%装置输出下在顶点上以75Hz的频率递送。
■主要结果是青年躁狂量表（YMRS）总评分和缓解率降低（与基线相比，YMRS总评分降低50%以上）。对主要结局进行了意向治疗（ITT）分析和重复测量方差分析。
■ECT组20名患者（平均[SD]年龄，31.6[8.6]岁；12名男性[60.0%]）和MST组22名患者（平均[SD]年龄，34.8[9.8]岁；15名男性[68.2%]）被纳入ITT分析。ECT组为95.0%(95%CI,85.4%-100%),MST组为86.4%(95%CI,72.1%-100%)。两组间YMRS降低率（z=-0.82；95%CI，-0.05~0.10；P=0.41）和有效率（χ2=0.18；95%CI，-0.13~0.31；P=0.67）无显著差异。按时间分组的交互在语言领域是显著的(F1,24=7.17;P=0.01)，在接受MST的患者中保存完好，但在接受ECT的患者中恶化。两组均无严重不良反应报告。
■这些研究结果表明，MST与双相躁狂症的高反应率和较少的认知障碍相关，它可能是双相躁狂症的替代疗法。
■ClinicalTrials.gov标识符：NCT03160664。
