A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study
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BACKGROUND: Intermittent theta burst stimulation (iTBS) is a newer form of repetitive transcranial magnetic stimulation (rTMS) for patients with treatment resistant depression (TRD). Applying multiple daily iTBS sessions may enable patients to achieve remission more rapidly. OBJECTIVE: We compared the efficacy and tolerability of a twice-daily versus once-daily iTBS protocol in patients with TRD. We hypothesized that twice-daily iTBS would result in a greater improvement in depression scores compared to once-daily iTBS. METHODS: 208 participants (131 females) with TRD were randomized to receive either iTBS (600 pulses) delivered twice-daily with a 54-min interval between treatments or once-daily (1200 pulses) with 1 sham treatment with the same interval between treatments, to ensure equal levels of daily therapeutic contact and blinding of patients and raters. The primary outcome measure was change in depression scores on the Hamilton Rating Scale for Depression (HRSD-17) after 10 days of treatment and 30 days of treatments. RESULTS: HRSD-17 scores improved in both the twice-daily and once-daily iTBS groups; however, these improvements did not significantly differ between the two groups at either the 10-day or 30-day timepoints. Response and remission rates were low (<10%) in both groups after 10 days and consistent with prior reports at 30 days; these rates did not differ between the treatment groups. CONCLUSIONS: These results suggest that twice-daily iTBS does not accelerate response to iTBS and is not different from once-daily treatment in terms of improving depressive symptoms in patients with TRD. Clinicaltrials.gov ID: NCT02729792 (https://clinicaltrials.gov/ct2/show/NCT02729792).
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Numerous studies of TBS for TRD have been published, but studies tend to report reduction in depressive symptoms as the sole outcome measure, focus on neuroimaging, or report other clinical outcomes.
“Numerous studies of TBS for TRD have been published, but studies tend to report reduction in depressive symptoms as the sole outcome measure (e.g., Bakker et al., 2015;Blumberger et al., 2018;Blumberger et al., 2021;Bouaziz et al., 2023;Bulteau et al., 2022;Caeyenberghs et al., 2018;Chen et al., 2021;Lee et al., 2021;Mehta et al., 2022;Spitz et al., 2022;Spurny-Dworak et al., 2022;Stöhrmann et al.”
From Neurocognitive effects of theta burst stimulation for treatment-resistant depression in adults: A systematic review and recommendations for future research (2025) · cites this paper as Blumberger et al., 2021
The Results (§3.1) report reduced depressive-symptom scores in both treatment groups, so this paper supports that part of the citation. But the Procedures (§2.2) also identify adverse events, pain intensity, serious adverse events, and treatment discontinuation as reported outcomes; depressive symptoms were not the sole outcome measure. Page numbers were not available in our copy. (LLM, conf=0.87)
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- Authors
- Blumberger, D. M., Vila-Rodriguez, F., Wang, W., Knyahnytska, Y., Butterfield, M., Noda, Y., Yariv, S., Isserles, M., Voineskos, D., Ainsworth, N. J., Kennedy, S. H., Lam, R. W., Daskalakis, Z. J., & Downar, J.
- Affiliations
- Centre for Addiction and Mental Health (CA)
- University of British Columbia (CA)
- Keio University (JP)
- Technion – Israel Institute of Technology (IL)
- Jerusalem Mental Health Center (IL)
- St. Michael's Hospital (CA)
- University of California San Diego (US)
- University Health Network (CA)
- Corresponding author
- Blumberger, Daniel M.
- ORCID
- Venue
- Brain Stimulation
- Publisher
- Elsevier BV
- Published
- 2021-11
- Volume
- 14
- Issue
- 6
- Pages
- 1447-1455
- ISSN
- 1876-4754 (ISSN-L)
- 1935-861X
- OpenAlex
- W3200522299
- Cited by
- 81
- References
- 30
- Citations by year
- 2026: 20 · 2025: 20 · 2024: 13 · 2023: 15 · 2022: 12 · 2021: 1
- FWCI
- 4.10
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Brain stimulation (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Toronto General and Western Hospital Foundation
- Health Canada
- Family Care Foundation
- Arrell Family Foundation
- Fondation Brain Canada
- Topics
- Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- intermittent theta burst stimulation, treatment-resistant depression, repetitive transcranial magnetic stimulation, treatment response and remission
- MeSH terms
- Canada, Depression, Female, Humans, Biomarkers, Treatment Outcome, Prefrontal Cortex, Transcranial Magnetic Stimulation
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