SAINT in Postpartum Depression (PPD)

Overview

This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment. It will enroll 192 women within six months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to six months. The trial's main goal is to see if SAINT leads to rapid improvement in depression, while also evaluating its safety, durability of benefit, and impact on mother-infant bonding.

SAINT combines an accelerated rTMS stimulation protocol with individualized functional connectivity (FC)-based brain targeting. It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment. SAINT is FDA cleared for the treatment of major depressive disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. This is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women who are non-responsive to standard of care treatment. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in PPD among women unresponsive to standard care. Unlike traditional treatments, SAINT is designed to provide rapid relief from depressive symptoms, potentially within just a few days. The rationale for this study is based on the need for a faster, more effective treatment option that can quickly stabilize the mental health of new mothers, allowing them to better care for their infants and themselves. This study will primarily benefit women who have recently given birth and are struggling with a postpartum depression. These women often face intense emotional distress that can interfere with their ability to bond with their newborns and manage daily responsibilities. By offering a quicker route to recovery, SAINT has the potential to restore these mothers' mental health, enabling them to fully engage in their new role as parents. The study also aims to include a diverse population, ensuring that the benefits of SAINT are generalizable. There are two phases in this study: 1. A blinded phase where participants will be randomized to receive 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo) treatment. 2. After the acute treatment, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they will be offered 1 course of active SAINT treatment. (5 days). Total study duration for each participant is approximately 7.5 months.