Efficacy of adjunctive theta burst transcranial magnetic stimulation in acute mania: A randomized and placebo-controlled study

Transcranial magnetic stimulation (TMS) has been suggested as a non-invasive stimulation treatment modality in bipolar disorder. However, the efficacy of repetitiver TMS in acute phase mania is unclear. The aim of this study is to assess the efficacy of theta burst stimulation (TBS) as an add-on therapy in the treatment of acute phase mania stimulation both right and left dorsolateral prefrontal cortex (DLPFC) in a randomized and sham-controlled design. Forty right-handed patients between 18 and 59 years were randomly allocated to active and sham groups. Then, intermittent TBS (right DLPFC) and cTBS (left DLPFC) sessions (half an hour apart) were delivered in two sessions per day for 5 days in a week. Youngs Mania Rating Scale (YMRS) and Clinical global impression-Bipolar Disorder (CGI-BP) were assessed at baseline and at 7th and 21st days. Our study fails to show a significant effect on of active stimulation in comparison to sham over psychopathology YMRS (F = 0.300; P ≤ 0.612), CGIBP-S (F = 0.432; P = 0.562), CGIBP-P (F = 0.202; P = 0.701), and CGIBP-W (F = 200; P = 0.705) in intention to treat protocol across 21 days. Minimal side effects were reported and none of the patients discontinued TBS citing side effects. We conclude that it is safe and well tolerated yet has inconclusive short-term therapeutic benefits. Trials using better localization technique with large sample, longer duration, and better dosing protocols are needed.