Trial reportBMC medicine2026
Bilateral sequential accelerated theta-burst stimulation for treatment-resistant depression: an open-label randomized controlled trial.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
14 authors.
Funding
Abstract
backgroundThis study aims to evaluate the clinical effectiveness and feasibility of a novel bilateral sequential accelerated theta-burst stimulation (BS-aTBS) protocol in treatment-resistant depression (TRD) patients, compared to a standard intermittent TBS (a-iTBS) protocol.
methodsIn this randomized controlled clinical trial, 94 TRD patients were randomly assigned to receive either BS-aTBS (n = 46) or a-iTBS (n = 48). Both groups delivered 10 daily TBS sessions (1800 pulses/session) for 5 consecutive days. The primary outcome was score on the 24-item Hamilton Depression Rating Scale (HDRS-24) after treatment, normalized to baseline (week 0).
resultsBoth BS-aTBS and a-iTBS protocols significantly reduced HDRS-24 scores by week 1 (65.52% vs. 54.32%, p = 0.008) and week 5 (77.10% vs. 67.77%, p = 0.006), and the BS-aTBS group showed significantly greater symptom improvement at both time points. Compared to a-iTBS, the BS-aTBS yielded higher response rates at week 1 (78.26% vs. 58.33%, p = 0.038) and week 5 (93.48% vs. 77.08%, p = 0.026), and elicited greater alleviation for anxiety and suicidal ideation at week 5. Moreover, clinical improvement on sleep quality and cognitive abilities was larger in the BS-aTBS group, and the effects on anhedonia and alexithymia were comparable between the two protocols. No serious adverse events were observed.
conclusionsThe BS-aTBS protocol provided rapid and well-tolerated antidepressant effects in TRD patients lasting for 1 month, with additional benefits for anxiety and suicidal ideation. Considering its clinical advantages and shortened treatment time, the BS-aTBS may serve as a promising treatment protocol for TRD patients with high feasibility and efficiency.
trial registrationThis trial was registered at Chinese Clinical Trial Registry (ChiCTR2400091459).
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