Accelerated Theta-Burst Stimulation Protocol Improves Treatment-Resistant Depression
A novel 78-minute accelerated theta-burst stimulation (aTBS) protocol reduced depression severity in patients with treatment-resistant depression (TRD), according to results from a randomized clinical trial published in JAMA Psychiatry.
The triple blinded, sham-controlled study investigated whether intermittent TBS (iTBS), already an established TRD treatment, would offer stronger antidepressant effects if provided more than once daily. Researchers tested the safety and efficacy of a pragmatic aTBS protocol in adults with major depression experiencing a TRD episode. The study took place at a single center in São Paulo, Brazil, and included patients with a Hamilton Depression Rating Scale, 17-item (HDRS-17) score of 17 or higher.
“Participants received 45 active or sham stimulation sessions over 15 weekdays, with 3 iTBS sessions (1200 pulses each) per day, spaced 30 minutes apart and targeting the left dorsolateral prefrontal cortex using a craniometric approach,” wrote first author Matheus Rassi F. Ramos, MD, of the University of São Paulo Medical School in São Paulo, Brazil, and study coauthors.
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Of the 100 patients enrolled and randomized to either active or sham treatment, 89 finished the study.
At week 5, Hamilton Depression Rating Scale scores decreased an average 54.7% in the aTBS group compared with 31.87% in the sham group in the intention-to-treat analysis. Specifically, HDRS-17 scores fell a mean 9.68 points in the aTBS group and 5.57 points in the sham group.
Rates of response, defined as a 50% or greater improvement in HDRS-17 score, and remission were both higher in the aTBS group, the study found.
Scalp pain was reported by 17.4% of patients in the aTBS group and 4.4% in the sham group. Both aTBS and sham interventions were considered well-tolerated, according to the study.
During an open-label phase that offered additional aTBS sessions for patients who had not achieved a response, 75% of patients opted for the added sessions.
“In this triple-blinded, sham-controlled randomized clinical trial, a pragmatic aTBS protocol using only 3 iTBS sessions per day and a nonexpensive, non-neuronavigated approach was found to be safe and effective for TRD,” researchers concluded.
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