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Theta-burst stimulation (TBS) efficacy, safety, and tolerability in major depressive episodes of bipolar I disorder: randomized, controlled, double-blind and parallel-group clinical trial


The pharmacological treatment of major depressive episodes of bipolar disorder (BD) stands out for its suboptimal efficacy rates, low tolerability and adherence, delayed onset of action, and iatrogenic mood switches. The use of repetitive transcranial magnetic stimulation (rTMS) is as an effective, safe and well-tolerated alternative in the treatment of unipolar and bipolar depressive episodes. Recently, a new rTMS protocol was introduced, the theta-burst stimulation (TBS), which comparative studies have demonstrated similar efficacy with a shorter time interval than conventional rTMS. Most clinical trials carried out to date have evaluated the use of TBS in unipolar patients or mixed unipolar and bipolar patients. The efficacy of TBS exclusively in BD has not been properly studied. We will conduct a 6-week randomized, double-blind, sham-controlled and parallel-group clinical trial comprising 5x/week for the first 3 weeks and then 2x/week for a further 3 weeks of active or sham TBS. We will be enroll 60 patients aged between 18 and 65 years with a diagnosis of bipolar I disorder in current moderate or severe major depressive episode resistant to at least two first or second-line pharmacological trials, according to the CANMAT guidelines. The primary outcome will be the assessment of TBS efficacy through the difference in 17-item Hamilton Depression Scale score from baseline to the end of week 6 of intervention between the active and sham groups. (AU)

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