Introduction: International guidelines recommend treating adults with depressive disorders with repetitive transcranial magnetic stimulation (rTMS). rTMS protocols have varied over time, but the transition from long high-frequency rTMS protocols (eg, 10 Hz) to theta-burst stimulation constitutes an important methodologic change, enabling clinicians to provide rTMS as a short, effective, and well-tolerated regime. Accordingly, the clinical protocols offered in the Department of Psychiatry and Psychotherapy at LMU Hospital have changed during the last decade; this marks our first analysis of treatment outcomes using real-world data (RWD) from 2012 to 2022.
Materials and methods: Between 2012 and 2022, 207 patients receiving rTMS treatment were included in this retrospective analysis using RWD. Over time, rTMS protocols varied, the most prominent being 10-Hz rTMS (referred to as 10 Hz) and intermittent theta-burst stimulation (iTBS). In total, 83 patients completed a treatment phase of three weeks (ie, 15 sessions total) following one of these protocols and were examined using the Beck Depression Inventory (BDI) at baseline and after treatment.
Results: Both 10-Hz and iTBS groups showed a comparable overall reduction of depressive symptoms, with similar rates of remission (defined by the BDI score >13 points, 33%/40% for 10 Hz/iTBS), response (defined as ≥50% score reduction; 28%/37% for 10 Hz/iTBS), and patients with symptom improvement (defined as any reduction in score; 67%/70% for 10 Hz/iTBS). An exploratory, BDI-based item-level analysis revealed that effects were largely not item- or protocol-specific.
Conclusion: RWD may serve as valuable comparator to results from randomized, clinical trials (RCTs). The results in our clinical sample indicate clinically relevant response rates with comparative efficacy for both, 10Hz and iTBS protocols. Both protocols were comparable to recent RCTs in terms of clinical efficacy. With comparable efficacy to 10 Hz and greater time efficiency, iTBS is an established, pragmatic, and scalable treatment option in real-world clinical settings.
Keywords: Intermittent theta-burst stimulation (iTBS); major depressive disorder (MDD); real-world data (RWD); repetitive transcranial magnetic stimulation (rTMS); retrospective cohort study.
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