Abstract
Accelerated repetitive transcranial magnetic stimulation (rTMS) protocols are being increasingly studied because of their potential to provide quicker and enhanced treatment efficacy. However, there is a lack of accelerated deep TMS with H1-coil (adTMS) treatment research. This randomized pilot study investigated the efficacy and safety of adTMS protocols. Twenty-eight TRD patients received 20-min sessions twice daily for 10 or 15 days. Primary outcomes were changes in Hamilton Depression Rating Scale (HDRS) scores and discontinuation because of adverse events (AE). Secondary outcomes were response, remission, daily changes in Beck Depression Inventory-II (BDI-II) scores, and AE incidence. HDRS scores decreased by 13 (95% CI 11–17; 59%, 95% CI 45–73%) and 13 (95% CI 11–14; 62%, 95% CI 54–69%) points in the 10- and 15-day protocols, respectively. The adjusted difference between the two protocols was not significant or clinically relevant. Remission was achieved by 38% and 42% after 10-day and 15-day protocols, respectively. The intervention was discontinued because of AEs in 3/33 (9%) patients. The BDI-II decreases were significant and clinically relevant during the first 8 days. Twice-daily adTMS for 10 days seems to be safe and effective, with rapid clinical benefits during the first week of treatment. These promising results warrant further investigation in larger randomized clinical trials comparing adTMS with the standard dTMS protocol.
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Funding
Croatian Health Insurance Fund funded the treatments and all other costs were covered by Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia. There were no commercial or financial involvements relevant to this study.
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Conceptualization IF, IŠF, ŽB; formal analysis and investigation: IF, IŠF, ŽB, ŽM, SS, TG, NG, KM, IO; writing—original draft preparation: IF, IŠF, ŽB; writing—review and editing: IF, IŠF, ŽB, ŽM, TG, NG, SZP, IO; funding acquisition: IF; resources: IF, ŽM, TG, IO; supervision: IF.
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IF has received equipment for research from Brainsway. He has served on a scientific advisory board for Janssen and Brainsway and received personal fee from Eli Lilly and Company, Lundbeck, Pfizer, TEVA, Belupo. For the remaining authors, no conflicts of interest were declared.
Ethical standards
The study protocol was approved by the Ethics committee of the Psychiatric Hospital “Sveti Ivan”, Zagreb, Croatia, and all participants verified their informed consent by signing the Consent form. We have not obtained an independent Ethics committee approval. This pilot study was part of the main randomized controlled trial whose protocol was registered at ClinicalTrials.gov (NCT03718013) on October 24, 2018. The study was conducted in compliance with the World Health Organization Declaration of Helsinki of 1975, as revised in 2013 [17].
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Communicated by Andrea Schmitt.
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Filipčić, I., Šimunović Filipčić, I., Sučić, S. et al. A pilot investigation of accelerated deep transcranial magnetic stimulation protocols in treatment-resistant depression. Eur Arch Psychiatry Clin Neurosci 271, 49–59 (2021). https://doi.org/10.1007/s00406-020-01141-y
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DOI: https://doi.org/10.1007/s00406-020-01141-y