Treatment of Bipolar Disorder with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-ControlledClinicalTrial

Journal: Neuropsychopharmacology 42(13):2593-2601 (2017)

Authors: D.F Tavares, M.L Myczkowski, R.L Alberto, L Vallengo, R.M Rios, P Gordon, B de-Sampaio-Junior, I Klein, C.G Mansur, M.A marcolin, B lafer, R.A Moreno, W Gattaz, Z.J Daskalakis, A.R Brunoni

Background:

Bipolar Disorder (BPD) is a highly prevalent condition with limited therapeutic options. Deep (H1-coil) transcranial magnetic stimulation(Deep TMS™) is a novel TMS modality with established efficacy for unipolar depression.

Objective:

This study was a randomized sham-controlled trial to evaluate the efficacy and safety of Deep TMS in treatment-resistant BPD patients.

Methods:

Fifty patients received 20 sessions of active or sham Deep TMS over the left dorsolateral prefrontal cortex (H1-coil, 55 18 Hz 2 s 120% MT trains). The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Secondary outcomes were changes from baseline to the end of the follow-up phase (week 8), and response and remission rates. Safety was assessed using a Deep TMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS).

Results:

Out of 50 patients, 43 finished the trial. There were 2 and 5 dropouts in the sham and active groups, respectively. Active Deep TMS was superior to sham at end point (difference favoring Deep TMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Remission rates were not statistically different. No TEMS episodes were observed.

Conclusions:

Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar patients receiving adequate pharmacotherapy.

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