SAINT proven safe for patients with treatment-resistant depression

The Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) is safe for use and is well tolerated by patients with treatment-resistant depression, a study has shown.

SAINT is an accelerated, high-dose resting-state functional connectivity magnetic resonance imaging (fcMRI)-guided intermittent theta-burst stimulation (iTBS) protocol for treatment-resistant depression.

The authors assessed the feasibility, tolerability and preliminary efficacy of SAINT in 22 patients with treatment-resistant depression. They used fcMRI in each participant to individually target the region of the left dorsolateral prefrontal cortex (DLPFC) most anticorrelated with subgenual anterior cingulate cortex (sgACC).

Participants underwent 50 iTBS sessions (1,800 pulses per session, 50-minute intersession interval), delivered as 10 daily sessions over 5 consecutive days at 90 percent resting motor threshold (adjusted for cortical depth). Neuropsychological testing was performed before and after SAINT.

Twenty-one patients were included in the analysis following the withdrawal of one participant. Of these, 19 (90.5 percent) met the remission criteria (defined as a score <11 on the Montgomery-Åsberg Depression Rating Scale). In intent-to-treat analysis, the same number of participants met the remission criteria (19 of 22; 86.4 percent).

In addition, no negative cognitive side effects were shown in neuropsychological testing.

“Double-blinded sham-controlled trials are needed to confirm the remission rate observed in this initial study,” the authors said, noting that new antidepressant treatments that are effective, safe, tolerable and rapid acting are essential.

A noninvasive brain stimulation treatment, iTBS has been approved by the US Food and Drug Administration for treatment-resistant depression.

According to the authors, recent methodological advances suggest that the current iTBS protocol has several points for improvement. It can be improved by “treating patients with multiple sessions per day at optimally spaced intervals, applying a higher overall pulse dose of stimulation, and precision targeting of the left DLPFC to sgACC circuit.”