Treatment of major depression with bilateral theta burst stimulation: A randomized controlled pilot trial

Background: Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression (MD) include theta burst stimulation (TBS), a patterned form of rTMS. Here, we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex (dIPFC) in patients with MD in additon to ongoing medication and psychotherapy. Methods: In this randomized-controlled trial, thirty-two patients with MD were treated for six weeks (thirty sessions) with either successively intermittent, activity enhancing TBS (iTBS) to the left and continuous, inhibiting TBS (cTBS) to the right dIPFC or with bilateral sham stimulation. Primary outcome measure was the proportion of treatment response defined as a Montgomery-Asberg Depression Raring Scale (MADRS) <= 50% compared to baseline. Secondary outcomes comprised response and remission rates of the Hamilton Depression Raring Scale (HAMD) and the Beck Depression Inventory (BM). Results: A larger number of responders were found in the cTBS (n=9) compared to the sham-siimularion (n=4) group (odds ratio: 3.86; Wald chi(2)=3.9, p=0.048). On secondary endpoint analysis, patient-reported outcome as assessed by the BDI. pointed towards a higher rare of remitters in the cTBS (n=6) than in the sham (n=1) group (odds ratio: 9; Wald chi(2)=3.5, p=0.061). Limitations: With regard to the pilot character of the study and the small sample size, the results have to be considered as preliminary. Conclusions: These findings provide first evidence that six weeks treatment of MDD with iTBS to the left and cTBS to the right dIPFC for six weeks is safe, feasible and superior to sham stimulation applied add-on to pharmacological and psychotherapeutic treatment. (C) 2013 Elsevier B.V. All rights reserved.