The efficacy and safety of theta burst stimulation for bipolar depression: a systematic review and meta-analysis

Randomized controlled trials demonstrating the efficacy of theta burst stimulation (TBS) for bipolar depression have been accumulating. However, the previous meta-analysis failed to detect a significant difference in efficacy compared to sham stimulation.

A comprehensive search for randomized controlled trials was carried out using multiple databases, including PubMed, the Cochrane Library, CINAHL, and ClinicalTrials.gov. A random-effects meta-analysis was employed to assess and compare the antidepressant efficacy, tolerability, and acceptability of TBS versus sham stimulation.

A total of 7 randomized sham-controlled trials, encompassing 168 participants, met the inclusion criteria. TBS demonstrated superior antidepressant efficacy over sham stimulation, with a standardized mean difference of 0.67 (95 % confidence interval [CI]: 0.03 to 1.31). The odds ratio (OR) for clinical response favored TBS (OR = 2.93, 95 % CI: 1.32-6.52), while the OR in remission was not statistically significant (OR = 2.12, 95 % CI: 0.85-5.27). Acceptability, assessed by all-cause discontinuation, was comparable between groups (OR = 0.48, 95 % CI: 0.12-1.96).

Theta burst stimulation appears to be a promising, effective, and safe treatment for bipolar depression. Further large-scale and long-term randomized controlled trials are warranted.