AUTHOR=Lee Jangwon , Lee Chan Woo , Jang Yoonjeong , You Ji Seon , Park Yun Seong , Ji Eunjeong , Yu Hyeona , Oh Sunghee , Ryoo Hyun A. , Cho Nayoung , Park Ji Yoon , Yoon Joohyun , Baek Ji Hyun , Park Hye Youn , Ha Tae Hyon , Myung Woojae 

TITLE=Efficacy and safety of daily home-based transcranial direct current stimulation as adjunct treatment for bipolar depressive episodes: Double-blind sham-controlled randomized clinical trial

JOURNAL=Frontiers in Psychiatry

VOLUME=13

YEAR=2022

URL=https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.969199

DOI=10.3389/fpsyt.2022.969199

ISSN=1664-0640

ABSTRACT=<sec><title>Background</title><p>Although transcranial direct current stimulation (tDCS) is known to be a promising therapeutic modality for unipolar depression, the efficacy and safety of tDCS for bipolar depressive episodes (BD) are still unknown and clinical trials of home-based tDCS treatment are scarce. As a result, we set out to investigate the efficacy and safety of home-based tDCS for the treatment BD.</p></sec><sec><title>Methods</title><p>Participants (<italic>n</italic> = 64), diagnosed as bipolar disorder as per the diagnostic and statistical manual of mental disorders (DSM-5), were randomly assigned to receive tDCS. Hamilton Depression Rating Scale (HDRS-17) scores were measured at the baseline, week 2, 4, and 6, and home-based tDCS (for 30 min with 2 mA) was self-administered daily.</p></sec><sec><title>Results</title><p>Of the 64 patients (15.6% bipolar disorder I, 84.4% bipolar disorder II), 41 patients completed the entire assessment. In the intention-to-treat analysis, time-group interaction for the HDRS-17 [<italic>F</italic><sub>(3, 146.36)</sub> = 2.060; <italic>p</italic> = 0.108] and adverse effect differences between two groups were not statistically significant, except the pain score, which was higher in the active group than the sham group (week 0–2: <italic>p</italic> &lt; 0.01, week 2–4: <italic>p</italic> &lt; 0.05, and week 4–6: <italic>p</italic> &lt; 0.01).</p></sec><sec><title>Conclusion</title><p>Even though we found no evidence for the efficacy of home-based tDCS for patients with BD, this tool was found to be a safe and tolerable treatment modality for BD.</p></sec><sec><title>Clinical trial registration</title><p>[<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/show/NCT03974815" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/show/NCT03974815</ext-link>], identifier [NCT03974815].</p></sec>