To evaluate the antidepressant effects of once-daily intermittent theta-burst stimulation (iTBS) compared with sham stimulation in adults with major depressive disorder (MDD).
Approach:
Study Design: A single-center, prospective, randomized, double-blind, sham-controlled superiority clinical trial with 1:1 allocation, stratified by sex.
Participants: Self-referred adults aged 22-65 with a prior diagnosis of MDD, a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or more, and low suicide risk.
Intervention: Participants received 10 sessions of once-daily iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) over 6 weeks.
Outcome Measures: Primary outcome was the difference in depression ratings at day 10 using MADRS and Beck Depression Inventory–II (BDI-II).
Key Findings:
iTBS was applied once daily to the left DLPFC, delivering 600 pulses at 120% of the resting motor threshold.
The study adhered to CONSORT guidelines and was approved by the Regional Committee for Medical and Health Research Ethics.
Participants were blinded to their treatment allocation, while operators were not.
Interpretation:
The study aims to provide clearer evidence on the efficacy of iTBS compared to sham stimulation in treating MDD, addressing limitations of previous studies.
Limitations:
Most existing evidence comes from active comparator trials, limiting the estimation of treatment effects.
Sham-controlled iTBS studies are limited and often use heterogeneous patient populations.
Conclusion:
The study seeks to clarify the antidepressant effects of iTBS in MDD through a rigorous sham-controlled design.
by Marte C. Ørbo, Ole K. Grønli, Mats S. Brochs, Oddgeir Friborg, Torgil Riise Vangberg, Runar Selaas, Camilla Larsen, Matthias Mittner, Zsolt Turi, Gábor Csifcsák, Per M. Aslaksen
