Treatment of depression with antidepressants is partly effective. Transcranial alternating current stimulation can provide a non-pharmacological alternative for adult patients with major depressive disorder. However, no study has used the stimulation to treat first-episode and drug-naïve patients with major depressive disorder. We used a randomized, double-blind, sham-controlled design to examine the clinical efficacy and safety of the stimulation in treating first-episode drug-naïve patients in a Chinese Han population. From 4 June 2018 to 30 December 2019, 100 patients were recruited and randomly assigned to receive 20 daily 40-min, 77.5 Hz, 15 mA, one forehead and two mastoid sessions of active or sham stimulation (n = 50 for each group) in four consecutive weeks (Week 4), and were followed for additional 4-week efficacy/safety assessment without stimulation (Week 8). The primary outcome was a remission rate defined as the 17-item Hamilton Depression Rating Scale (HDRS-17) score ≤ 7 at Week 8. Secondary analyses were response rates (defined as a reduction of ≥ 50% in the HDRS-17), changes in depressive symptoms and severity from baseline to Week 4 and Week 8, and rates of adverse events. Data were analysed in an intention-to-treat sample. Forty-nine in the active and 46 in the sham completed the study. Twenty-seven of 50 (54%) in the active treatment group and 9 of 50 (18%) in the sham group achieved remission at the end of Week 8. The remission rate was significantly higher in the active group compared to that in the sham group with a risk ratio of 1.78 (95% confidence interval, 1.29, 2.47). Compared with the sham, the active group had a significantly higher remission rate at Week 4, response rates at Weeks 4 and 8, and a larger reduction in depressive symptoms from baseline to Weeks 4 and 8. Adverse events were similar between the groups. In conclusion, the stimulation on the frontal cortex and two mastoids significantly improved symptoms in first-episode drug-naïve patients with major depressive disorder and may be considered as a non-pharmacological intervention for them in an outpatient setting.

Transcranial alternating current stimulation for treating depression: a randomized controlled trial / Wang, Hongxing; Wang, Kun; Xue, Qing; Peng, Mao; Yin, Lu; Gu, Xuecun; Leng, Haixia; Lu, Juan; Liu, Hongzhi; Wang, Di; Xiao, Jin; Sun, Zhichao; Li, Ning; Dong, Kai; Zhang, Qian; Zhan, Shuqin; Fan, Chunqiu; Min, Baoquan; Zhou, Aihong; Xie, Yunyan; Song, Haiqing; Ye, Jing; Liu, Aihua; Gao, Ran; Huang, Liyuan; Jiao, Lidong; Song, Yang; Dong, Huiqing; Tian, Zichen; Si, Tianmei; Zhang, Xiangyang; Li, Xinmin; Kamiya, Atsushi; Cosci, Fiammetta; Gao, Keming; Wang, Yuping. - In: BRAIN. - ISSN 1460-2156. - STAMPA. - 145:(2022), pp. 83-91. [10.1093/brain/awab252]

Transcranial alternating current stimulation for treating depression: a randomized controlled trial

Cosci, Fiammetta;
2022

Abstract

Treatment of depression with antidepressants is partly effective. Transcranial alternating current stimulation can provide a non-pharmacological alternative for adult patients with major depressive disorder. However, no study has used the stimulation to treat first-episode and drug-naïve patients with major depressive disorder. We used a randomized, double-blind, sham-controlled design to examine the clinical efficacy and safety of the stimulation in treating first-episode drug-naïve patients in a Chinese Han population. From 4 June 2018 to 30 December 2019, 100 patients were recruited and randomly assigned to receive 20 daily 40-min, 77.5 Hz, 15 mA, one forehead and two mastoid sessions of active or sham stimulation (n = 50 for each group) in four consecutive weeks (Week 4), and were followed for additional 4-week efficacy/safety assessment without stimulation (Week 8). The primary outcome was a remission rate defined as the 17-item Hamilton Depression Rating Scale (HDRS-17) score ≤ 7 at Week 8. Secondary analyses were response rates (defined as a reduction of ≥ 50% in the HDRS-17), changes in depressive symptoms and severity from baseline to Week 4 and Week 8, and rates of adverse events. Data were analysed in an intention-to-treat sample. Forty-nine in the active and 46 in the sham completed the study. Twenty-seven of 50 (54%) in the active treatment group and 9 of 50 (18%) in the sham group achieved remission at the end of Week 8. The remission rate was significantly higher in the active group compared to that in the sham group with a risk ratio of 1.78 (95% confidence interval, 1.29, 2.47). Compared with the sham, the active group had a significantly higher remission rate at Week 4, response rates at Weeks 4 and 8, and a larger reduction in depressive symptoms from baseline to Weeks 4 and 8. Adverse events were similar between the groups. In conclusion, the stimulation on the frontal cortex and two mastoids significantly improved symptoms in first-episode drug-naïve patients with major depressive disorder and may be considered as a non-pharmacological intervention for them in an outpatient setting.
145
83
91
Wang, Hongxing; Wang, Kun; Xue, Qing; Peng, Mao; Yin, Lu; Gu, Xuecun; Leng, Haixia; Lu, Juan; Liu, Hongzhi; Wang, Di; Xiao, Jin; Sun, Zhichao; Li, Ning; Dong, Kai; Zhang, Qian; Zhan, Shuqin; Fan, Chunqiu; Min, Baoquan; Zhou, Aihong; Xie, Yunyan; Song, Haiqing; Ye, Jing; Liu, Aihua; Gao, Ran; Huang, Liyuan; Jiao, Lidong; Song, Yang; Dong, Huiqing; Tian, Zichen; Si, Tianmei; Zhang, Xiangyang; Li, Xinmin; Kamiya, Atsushi; Cosci, Fiammetta; Gao, Keming; Wang, Yuping
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2158/1276933
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