Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial
Article
Woodham, R., Selvaraj, S., Lajmi, N., Hobday, H., Sheehan, G., Ghazi-Noori, A., Lagerberg, P., Rizvi, M., Kwon, S. S., Orhii, P., Maislin, D., Hernandez, L., Machado-Vieira, R., Soares, J. C., Young, A. H. and Fu, C. 2024. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nature Medicine. p. In Press. https://doi.org/10.1038/s41591-024-03305-y
Authors | Woodham, R., Selvaraj, S., Lajmi, N., Hobday, H., Sheehan, G., Ghazi-Noori, A., Lagerberg, P., Rizvi, M., Kwon, S. S., Orhii, P., Maislin, D., Hernandez, L., Machado-Vieira, R., Soares, J. C., Young, A. H. and Fu, C. |
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Abstract | Transcranial direct current stimulation (tDCS) has been proposed as novel treatment in major depressive disorder (MDD). The present study is fully remote, multisite, double-blind, placebocontrolled, randomized superiority trial of 10-week home-based tDCS in MDD. Participants were 18 years or older, with MDD in current depressive episode of at least moderate severity as measured by Hamilton Depression Rating Scale (HDRS) (mean 19.07+2.73). 174 participants (120 women) were randomised to active (n=87) (mean age 37.09+11.14 years) or sham (n=87) (mean age 38.32+10.92 years) treatment. tDCS sessions were 5 sessions per week for 3 weeks then 3 sessions per week for 7 weeks in 10-week trial, followed by 10-week open label phase. Each session was 30 minutes, anode over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC, active tDCS 2-mA, and sham tDCS 0-mA with brief ramp up and down to mimic active stimulation. In primary outcome, depressive symptoms showed significant improvement as measured by HDRS rating: active 9.41+6.25 point improvement (10-week mean 9.58+6.02) and sham 7.14+6.10 point improvement (10-week mean 11.66+5.96) (95% CI 0.51, 4.01, P = 0.012). There were no differences in discontinuation rates. In summary, 10-week home-based tDCS treatment with remotesupervision in MDD showed high efficacy, acceptability and safety. |
Journal | Nature Medicine |
Journal citation | p. In Press |
ISSN | 1546-170X |
Year | 2024 |
Publisher | Springer Nature |
Accepted author manuscript | License File Access Level Anyone |
Publisher's version | License File Access Level Anyone |
Digital Object Identifier (DOI) | https://doi.org/10.1038/s41591-024-03305-y |
Publication dates | |
Online | 21 Oct 2024 |
Publication process dates | |
Accepted | 17 Sep 2024 |
Deposited | 23 Sep 2024 |
Copyright holder | © 2024 The Authors |
Additional information | The author manuscript version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: http://dx.doi.org/10.1038/s41591-024-03305-y |
https://repository.uel.ac.uk/item/8y52w
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Publisher's version
s41591-024-03305-y.pdf | ||
License: CC BY 4.0 | ||
File access level: Anyone |
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