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

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

Research output: Contribution to journalArticlepeer-review

Abstract

Background: 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. Methods: Participants (n = 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. Results: 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 [F(3, 146.36) = 2.060; p = 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: p < 0.01, week 2–4: p < 0.05, and week 4–6: p < 0.01). Conclusion: 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. Clinical trial registration: [https://clinicaltrials.gov/show/NCT03974815], identifier [NCT03974815].

Original languageEnglish
Article number969199
JournalFrontiers in Psychiatry
Volume13
DOIs
StatePublished - 20 Sep 2022
Externally publishedYes

Keywords

  • bipolar depressive episodes
  • clinical trial
  • double-blind
  • efficacy
  • safety
  • transcranial direct current stimulation

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