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Extended course accelerated intermittent theta burst stimulation as a substitute for depressed patients needing electroconvulsive therapy

Neuropsychopharmacology volume 50, pages 685–694 (2025)Cite this article

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Abstract

In response to restrictions on electroconvulsive therapy (ECT) access during COVID-19, we designed a trial to assess the clinical outcomes service impacts, employing an extended course of accelerated intermittent theta burst stimulation (aiTBS), in patients with moderate to severe depression in need of ECT. This open label clinical trial was comprised of 3 phases: (i) an acute phase, where iTBS treatments were administered 8 times daily, for up to 10 days; (ii) a tapering phase of 2 treatment days per week for 2 weeks, followed by 1 treatment day per week for 2 weeks; and (iii) a symptom-based relapse prevention phase, whereby treatments were scheduled based on symptom re-emergence, for up to 6 months. Of the 155 patients who completed the acute phase of the study, the remission rate was 16.1%. The mean reduction from baseline on the HRSD-24 was 29.4% (p < 0.001) and the response rate was 25.2%. Of the 110 patients who completed the tapering phase, the mean reduction from baseline was 42.6% (p < 0.001) and response and remission rates were 49.6% and 34.8%, respectively. Of the 61 patients who were eligible for the relapse prevention phase, 43 completed, with a mean reduction from baseline of 60.1% (p < 0.001); 7 patients relapsed during this phase. This study demonstrated that an extended aiTBS protocol safely led to meaningful clinical outcomes in patients with severe depression, who otherwise would have received ECT, and thus reduced pressure on ECT services during the pandemic.

Trial Registration

ClinicalTrials.gov Identifier: NCT04384965 (https://clinicaltrials.gov/study/NCT04384965?term=NCT04384965&rank=1)

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Fig. 2: Clinical outcomes.

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Funding

This work was supported by the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centers of Ontario (grant no. 1000890). We would also like to acknowledge the Temerty Center Foundation and the Center for Addiction and Mental Health Foundation.

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Authors and Affiliations

  1. Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada

    Michelle S. Goodman, Alisson P. Trevizol, Gerasimos N. Konstantinou, Jonathan Downar, Tyler S. Kaster, Yuliya Knyahnytska, Daphne Voineskos & Daniel M. Blumberger

  2. Department of Psychiatry, University of Toronto, Toronto, ON, Canada

    Alisson P. Trevizol, Gerasimos N. Konstantinou, Jonathan Downar, Tyler S. Kaster, Yuliya Knyahnytska, Daphne Voineskos & Daniel M. Blumberger

  3. Department of Psychiatry, Laval University, Quebec City, QC, Canada

    David Boivin-Lafleur

  4. Royal Ottawa Mental Health Centre and Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada

    Ram Brender

  5. Department of Psychiatry, Queen’s University, Kingston, ON, Canada

    Yuliya Knyahnytska

  6. Non-Invasive Neurostimulation Therapies Laboratory, Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada

    Fidel Vila-Rodriguez

  7. School of Biomedical Engineering, University of British Columbia, Vancouver, BC, Canada

    Fidel Vila-Rodriguez

  8. Poul Hansen Family Centre for Depression, University Health Network, Toronto, ON, Canada

    Daphne Voineskos

  9. University of California San Diego, San Diego, CA, USA

    Zafiris J. Daskalakis

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Contributions

DMB conceived and designed the study. JD, FVR, ZJD, DV, TSK, YK provided input on the study design. APT, GNK, DBL, RB provided medical care or performed motor thresholds for participants. DMB and MSG developed the statistical analysis plan. MSG completed the data analysis. All authors contributed to the interpretation of data. MSG drafted the manuscript. All authors contributed to critical revisions of the manuscript. DMB had final responsibility for submission of the manuscript.

Corresponding author

Correspondence to Daniel M. Blumberger.

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Competing interests

DV holds the Labatt Family Professorship in Depression Biology, a University Named Professorship at the University of Toronto. She receives research support from CIHR, NIMH, the Center for Addiction and Mental Health (CAMH), The Center for Mental Health at University Health Network and the Department of Psychiatry at the University of Toronto. DV declares no biomedical interests or conflicts. FVR receives research support from CIHR, Brain Canada, Michael Smith Foundation for Health Research, Vancouver Coastal Health Research Institute, and Weston Brain Institute for investigator-initiated research. Philanthropic support from Seedlings Foundation. In-kind equipment support for investigator-initiated research from MagVenture. He has received honoraria for participation in an advisory board for Allergan. FVR is a volunteer director on the board of directors of the British Columbia Schizophrenia Society. TSK receives research support from the Canadian Institutes of Health Research, Patient-Centered Outcomes Research Institute, and the AFP Innovation Fund In the last 10 years, ZJD has received research and equipment in-kind support for an investigator-initiated study through Brainsway Inc and Magventure Inc. He also currently serves on the scientific advisory board for Brainsway Inc. His work has been supported by the National Institutes of Mental Health (NIMH), the Canadian Institutes of Health Research (CIHR), Brain Canada and the Temerty Family, Grant and Kreutzkamp Family Foundations. DMB receives research support from CIHR, NIH, Brain Canada and the Temerty Family through the CAMH Foundation and the Campbell Family Research Institute. He received research support and in-kind equipment support for an investigator-initiated study from Brainsway Ltd. He was the site principal investigator for three sponsor-initiated studies for Brainsway Ltd. He also received in-kind equipment support from Magventure for two investigator-initiated studies. He received medication supplies for an investigator-initiated trial from Indivior. He is a scientific advisor for Sooma Medical. He is the Co-Chair of the Clinical Standards Committee of the Clinical TMS Society (unpaid). The other authors declare no competing interests.

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Goodman, M.S., Trevizol, A.P., Konstantinou, G.N. et al. Extended course accelerated intermittent theta burst stimulation as a substitute for depressed patients needing electroconvulsive therapy. Neuropsychopharmacol. 50, 685–694 (2025). https://doi.org/10.1038/s41386-024-02007-w

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