To evaluate the clinical effects of intermittent theta-burst stimulation (iTBS) compared to sham stimulation in adults with major depressive disorder (MDD).
Approach:
Study Design: Randomized, participant- and rater-blinded, sham-controlled clinical trial.
Participants: Adults with major depressive disorder (MDD) receiving either active iTBS or sham stimulation.
Treatment Protocol: Participants in the active group received approximately one-third of a standard clinical course of iTBS (10 daily sessions) targeting the left dorsolateral prefrontal cortex.
Key Findings:
Active iTBS was associated with greater improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at midtreatment (day 5) and posttreatment (day 10) compared to sham.
No significant differences in response (iTBS: 39.5%; sham: 22.6%) or remission rates (iTBS: 34.2%; sham: 22.6%) at the end of treatment.
The lack of sustained differences at the 4-week follow-up suggests that a 10-session course may not be sufficient for lasting effects.
Interpretation:
The study indicates that while a 10-session course of iTBS leads to short-term reductions in depressive symptoms, it may not provide sustained clinical benefits.
Limitations:
The trial was likely underpowered to detect categorical outcomes.
Operator unblinding may have introduced bias affecting participant and rater perceptions.
Blinding integrity of raters was not assessed.
Conclusion:
The findings suggest that both early placebo responses and a rapid decrease in treatment effect may contribute to the observed outcomes.
