Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events.

IF 2.8 2区 医学 Q2 PSYCHIATRY
Ali-Reza Ghazi-Noori, Rachel D Woodham, Hakimeh Rezaei, Mhd Saeed Sharif, Elvira Bramon, Philipp Ritter, Michael Bauer, Allan H Young, Cynthia H Y Fu
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引用次数: 0

Abstract

Background: Current treatments for bipolar depression have limited effectiveness, tolerability and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy for major depressive episodes. tDCS is portable, safe, and individuals like having sessions at home. We developed a home-based protocol with real-time remote supervision. In the present study, we have examined the clinical outcomes, acceptability and feasibility of home-based tDCS treatment in bipolar depression.

Results: Participants were 44 individuals with bipolar disorder (31 women), mean age 47.27 ± 12.89 years, in current depressive episode of at least moderate severity (mean Montgomery Asberg Depression Rating Scale (MADRS) score 24.59 ± 2.64). tDCS was provided in bilateral frontal montage, F3 anode, F4 cathode, 2 mA, for 30 min, in a 6-week trial, for total 21 sessions, a follow up visit was conducted 5 months from baseline. Participants maintained their current treatment (psychotherapy, antidepressant or mood stabilising medication) or maintained being medication-free. A research team member was present by video conference at each session. 93.2% participants (n = 41) completed the 6-week treatment and 72.7% of participants (n = 32) completed the 5 month follow up. There was a significant improvement in depressive symptoms following treatment (mean MADRS 8.77 ± 5.37) which was maintained at the 5 month follow up (mean MADRS 10.86 ± 6.90), rate of clinical response was 77.3% (MADRS improvement of 50% or greater from baseline), and rate of clinical remission was 47.7% (MADRS rating of 9 or less). Acceptability was endorsed as "very acceptable" or "quite acceptable" by all participants. No participants developed mania or hypomania.

Conclusions: In summary, home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability in bipolar depression. Due to the open-label design, efficacy findings are preliminary.

Trial registration: ClinicalTrials.gov number NCT05436613 registered on 23 June 2022 https//www.

Clinicaltrials: gov/study/NCT05436613.

基于家庭的经颅直流电刺激治疗双相抑郁症:一项关于临床结果、可接受性和不良反应的开放标签治疗研究。
背景:目前治疗双相抑郁症的方法在有效性、耐受性和可接受性方面都很有限。经颅直流电刺激(tDCS)是一种新型的非侵入性脑部刺激方法,对重度抑郁发作有显著疗效。我们开发了一种具有实时远程监控功能的家庭方案。在本研究中,我们对基于家庭的 tDCS 治疗双相抑郁症的临床结果、可接受性和可行性进行了研究:在双侧额叶蒙太奇、F3阳极、F4阴极、2毫安、30分钟、为期6周的试验中,共进行了21次tDCS治疗,并在基线5个月后进行了随访。参与者继续接受当前的治疗(心理治疗、抗抑郁药物或稳定情绪药物)或继续不接受药物治疗。每次随访都有一名研究小组成员通过视频会议出席。93.2%的参与者(41 人)完成了为期 6 周的治疗,72.7%的参与者(32 人)完成了 5 个月的随访。治疗后抑郁症状明显改善(MADRS 平均值为 8.77 ± 5.37),并在 5 个月的随访中保持不变(MADRS 平均值为 10.86 ± 6.90),临床反应率为 77.3%(MADRS 比基线改善 50%或以上),临床缓解率为 47.7%(MADRS 评分为 9 分或以下)。所有参与者均表示 "非常可以接受 "或 "比较可以接受"。没有参与者出现狂躁或躁狂症:总之,在实时监督下进行的家庭tDCS治疗对双相抑郁症患者的临床症状有显著改善,且可接受性高。由于是开放标签设计,疗效结果尚属初步:ClinicalTrials.gov编号NCT05436613于2022年6月23日注册https//www.Clinicaltrials: gov/study/NCT05436613。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
International Journal of Bipolar Disorders
International Journal of Bipolar Disorders Medicine-Psychiatry and Mental Health
CiteScore
6.70
自引率
5.00%
发文量
26
审稿时长
13 weeks
期刊介绍: The International Journal of Bipolar Disorders is a peer-reviewed, open access online journal published under the SpringerOpen brand. It publishes contributions from the broad range of clinical, psychological and biological research in bipolar disorders. It is the official journal of the ECNP-ENBREC (European Network of Bipolar Research Expert Centres ) Bipolar Disorders Network, the International Group for the study of Lithium Treated Patients (IGSLi) and the Deutsche Gesellschaft für Bipolare Störungen (DGBS) and invites clinicians and researchers from around the globe to submit original research papers, short research communications, reviews, guidelines, case reports and letters to the editor that help to enhance understanding of bipolar disorders.
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