A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression
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.
• Reproductive Women ages 18-45 at the time of consent.
• Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
• 0-6 months postpartum.
• If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
• Severe depression as measured by MADRS ≥20 at screening.
• A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.
• Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.
• Agree to use effective contraception in the postpartum period for the study duration.
• Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.