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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.


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].

SUBMITTER: Lee J 

PROVIDER: S-EPMC9530445 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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.

Lee Jangwon J   Lee Chan Woo CW   Jang Yoonjeong Y   You Ji Seon JS   Park Yun Seong YS   Ji Eunjeong E   Yu Hyeona H   Oh Sunghee S   Ryoo Hyun A HA   Cho Nayoung N   Park Ji Yoon JY   Yoon Joohyun J   Baek Ji Hyun JH   Park Hye Youn HY   Ha Tae Hyon TH   Myung Woojae W  

Frontiers in psychiatry 20220920


<h4>Background</h4>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.<h4>Methods</h4>Participants (<i>n</i> = 64), diagnosed as bipolar disorder as per the diagnostic and  ...[more]

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