SAINT® Neuromodulation System for Depression and Suicidal Ideation in Major Depressive Disorder

This study is investigating a new treatment approach for people who are hospitalized with severe depression and have thoughts of suicide. It focuses on adults aged 18 to 75 who have Major Depressive Disorder, particularly those who have not responded to other treatments. The trial uses a special technology called SAINT, which stands for Stanford Accelerated Intermittent Neuromodulation Therapy, to see if it can effectively reduce symptoms of depression and suicidal thoughts. This research is important because it could provide a new, effective option for those who struggle with treatment-resistant depression and are at risk of harming themselves. Participants in the study will receive either the real SAINT treatment or a placebo version, known as sham treatment, to compare the results. The SAINT treatment involves using a device that delivers magnetic pulses to a specific part of the brain, the left dorsolateral prefrontal cortex, which is associated with mood regulation. This is done 10 times a day for five days. Researchers will measure changes in participants' depression symptoms using a standard rating scale before and after the treatment. The study aims to include 100 participants, divided into two groups of 50, and will look for differences in symptom improvement between those receiving the active treatment and those receiving the sham treatment.