In completed clinical trials, delivery of SAINT™ therapy for MDD has resulted in a significant reduction in depressive symptoms following the five-day treatment protocol.
Summary: Twenty-one participants with a mean baseline MADRS score of 28.6 (SD = 7.3) were enrolled in the study, entered remission the week following treatment with SAINT and adhered to the protocol. All 21 participants who received PCT as indicated by the proprietary algorithm returned to a state of remission.
Summary: Failure to achieve complete remission in treating Major Depressive Disorder (MDD) leads to increased morbidity, relapse rates and suicidality. This study was designed to examine brain functional connectivity changes in treatment-resistant patients (TRD) who participated in a clinical trial of SAINT (Stanford Neuromodulation Therapy). The results demonstrated that 1) functional connectivity changes support improved regulation of emotion and reward processing after SAINT; 2) Amygdala-centered network changes are central to the therapeutic effect of SAINT; and 3) the promise of the relationship between functional connectivity and clinical outcomes and explored any functional connectivity changes. This is the first evidence that the SAINT protocol has downstream effects on brain functional connectivity. This recently published clinical trial demonstrated the high efficacy of SAINT for TRD.
Summary: Depression is the leading cause of disability worldwide, and half of patients with depression have treatment-resistant depression. This clinical study tested the safety and effectiveness of personalized neurostimulation with a novel protocol for Major Depressive Disorder (MDD). The study was designed to address the limitations of the current intermittent theta-burst stimulation (iTBS). Results from the double-blinded randomized controlled trial (RCT) evaluating SAINT demonstrate that this novel approach has the promise to be a reproducible, rapid and effective treatment for severe, intractable depression. Fourteen people received active treatment, and another 15 people received sham (placebo) treatment. The results indicate that 79% of people in the active treatment arm entered remission—compared to people in the sham or control treatment arm, where 13% of the people entered remission from depression.
Summary: New antidepressant treatments are needed that are effective, rapid-acting, safe and tolerable. The study examined the feasibility, tolerability and preliminary effectiveness of SAINT neuromodulation treatment for treatment-resistant depression. Twenty-two participants with treatment-resistant depression received open-label SAINT treatment. One participant withdrew, leaving a sample size of 21. Nineteen of 21 participants (90.5%) entered remission based on the Montgomery-Åsberg Depression Rating Scale (MADRS). Neuropsychological testing demonstrated no negative cognitive side effects.
In these studies SAINT™ has been shown to be effective in the treatment of MDD, with approximately 80-90% of patients achieving remission of depression symptoms following the five-day treatment protocol. Treatment with SAINT™ is safe and well-tolerated according to results, indicating that this new treatment promises to be a rapid and effective treatment for treatment-resistant major depression.