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 12 months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.
• 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.
• 0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.
• 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.