61% of unmedicated treatment resistant depression patients who did not respond to acute TMS treatment responded after four weeks of twice weekly deep TMS in the Brainsway pivotal trial

Abstract

Background: An acute course of dTMS typically involves treatments delivered 5 days a week, for 4 weeks. Should more treatments be given if the patient has not responded? Data are needed to inform decisions about the best next steps for acute non-responders.

Objective: To characterize response among acute-phase non-responders in a randomized controlled trial of deep repetitive transcranial magnetic stimulation (dTMS) monotherapy for medication-resistant depression.

Methods: Summary statistics and Kaplan-Meier curves were used to characterize outcomes of 33 medication-free Brainsway™ dTMS non-responders to double blind but active treatment at the end of 4 weeks (20 sessions), who then continued double blind but active twice-weekly treatment for up to 12 additional weeks.

Results: 24 participants (72.7%) achieved responder status during at least one rating with dTMS continuation -- 20 (60.6%) within four weeks, with 13 (39.4%) consistently meeting response criteria for the duration of the study. 20 (63.6%) achieved remission status at some point during treatment continuation.

Conclusions: A significant proportion of acute course non-responders to dTMS treatment eventually respond with continued treatment. Continuing TMS treatment beyond the acute course for non-responders may result in eventual response in over half of these individuals.

Keywords: Clinical research; Randomized clinical trial; Transcranial magnetic stimulation; Treatment-resistant depression.