Journal: World Psychiatry 14(1):64-73 (2015)
Authors: Y Levkovitz, M Isserles, F Padberg, S.H. Lisanby, A Bystritsky, G Xia, A Tendler, Z.J Daskalakis, J.L Winston, P Dannon, H.M Hafez, I.M Reti, O.G Morales, T.E Schlaepfer, E Hollander, J.A Berman, M.M Husain, U Sofer, A Stein, S Adler, L Deutsch, F Deutsch, Y Roth, M.S George, A Zangen
Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (Deep TMS™) is a new technology allowing non-surgical stimulation of relatively deep brain areas.
This was the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of Deep TMS in MDD. This study led to FDA clearance of the BrainsWay Deep TMS device (FDA 510(k) Number K122288).
212 MDD outpatients, aged 22–68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode were recruited. They were randomly assigned to mono therapy with active or sham Deep TMS. Twenty sessions of Deep TMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively.
Deep TMS induced a 6.39 points improvement in HDRS-21 scores, while a 3.28 points improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the Deep TMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission:32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. Deep TMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred.
These results suggest that Deep TMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment.