A randomized, sham-controlled study of maintenance rTMS for treatment-resistant depression (TRD).

A few open-labeled studies have investigated the use of maintenance rTMS to prevent relapse for treatment-resistant depression (TRD) after rTMS treatment. We aim to assess the benefits of maintenance rTMS treatment for TRD patients who respond to rTMS treatment using a randomized, double-blind controlled design. Fifty eight TRD patients received rTMS over one month in an open-labeled design study (phase I). Responder patients were then randomized into active and sham high-frequency rTMS groups for the subsequent eleven months (phase II). The regularity of sessions was gradually reduced. The antidepressant effect of rTMS was evaluated using the Hamilton Depression Rating Scale (HDRS). Intention-to-treat analysis was performed to assess the effectiveness of maintenance sessions. Of the 58 patients included, 35 patients were responders after one month of active rTMS (phase I), and 17 patients were randomized for the maintenance sessions (phase II). The delta HDRS scores demonstrated a significant improvement between the first month and the fourth month in active group in comparison with sham group (phase II). There was no significant difference between these two groups for other periods of time. Repetitive TMS could represent a novel strategy for preventing relapse in TRD patients who respond to rTMS treatment. These results should be confirmed in a larger sample.

RCT Entities:   Population Interventions Outcomes