Review of: Wilkening J et al, Acta Psychiatr Scand 2022;146(6):540–556

Study Type: Randomized, quadruple-blind, sham-controlled crossover trial

Intermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation that uses higher magnetic frequencies to deliver the treatment in shorter sessions (3–10 minutes instead of 20–40 minutes). It was approved by the FDA in 2018 for treatment-resistant depression. This study examined the effects of iTBS on suicidality among patients with depression.

Eighty-one adults with moderate to severe major depression were enrolled in this six-week, quadruple-blind (patients, care providers, investigators, and raters were all blinded), sham-controlled crossover trial. Participants received five consecutive days of active or sham treatment, then switched to the other arm after a one-week break. Although the sham version had no magnetic pulses, the two treatments were indistinguishable. There were two primary outcomes: (1) change in baseline depression between the active and sham treatments as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and (2) change in suicidality between the active and sham treatments as measured by a composite “suicide score” (0–1) that the authors derived from the MADRS, the Hamilton Depression Scale, and the Beck Depression Inventory-II.

Participants’ depression and suicidality improved over the trial, with the greatest improvement occurring after the first five days of treatment in the active and sham groups, indicating an initial placebo effect. When the active and sham treatments were compared, the results showed that active treatment had a greater antidepressant effect (MADRS score improvement 5.02 with active, 2.11 for sham), but the antisuicide effects were similar. Dropouts were similar after active and sham treatments, and no serious adverse events occurred.

Carlat Take

In this study, iTBS treated depression but did not have antisuicide effects.