SAINT in Postpartum Depression (PPD)

Last updated: January 7, 2026
Sponsor: Magnus Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

SAINT Neuromodulation System

Sham SAINT Stimulation

Clinical Study ID

NCT07210255
CLN-0108
CDMRP-PR240070
  • Ages 18-45
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Reproductive Women ages 18-45 at the time of consent.

  2. Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset asassessed through the Quick Structured Clinical Interview for DSM-5.

  3. 0-12 months postpartum. Participants must be 0-12 months postpartum at screening andremain within 12 months postpartum at the 5-day post-treatment visit.

  4. If currently taking an antidepressant medication and/or receiving psychotherapy mustbe on a stable regimen for 30 days at the time of enrollment.

  5. Severe depression as measured by MADRS ≥20 at screening.

  6. A good candidate for repetitive transcranial magnetic stimulation (rTMS) asdetermined by a physician.

  7. Participants must be capable of giving informed consent. Participants must beproficient in English in order to comprehend study requirements.

  8. Agree to use effective contraception in the postpartum period for the studyduration.

  9. Willing and able to comply with all study procedures, complete required assessmentsand visits, and be available for the duration of the study.

Exclusion

Exclusion Criteria:

  1. Participant has attempted suicide in the last 6 months and/or expressed suicidalideation with intent as determined by physician assessment at the time ofenrollment.

  2. Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.

  3. Participant has active psychosis per investigator assessment.

  4. Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia,schizoaffective disorder and/or obsessive-compulsive disorder.

  5. Participant has an active eating disorder or substance use disorder in the past 6months and/or has a positive urine toxicity screen that the Principal Investigator (PI) deems exclusionary.

  6. Participant is using any exclusionary medications: high dose of benzodiazepines (>2mg lorazepam daily equivalent and/or >3 times per week) or medications that wouldinterfere with treatment with TMS as per PI or designee discretion.

  7. Participant has a history of untreated or insufficiently treated sleep apnea.

  8. Participant has a history of significant neurologic disease, including developmentaldisability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpectedseizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history ofsignificant head trauma.

  9. Any untreated major somatic illness such as hypertension/cardiovasculardisease/diabetes/endocrine disorders etc.

  10. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, knownbrain lesion).

  11. Contraindications to MRI (e.g., ferromagnetic metal in their body).

  12. Currently pregnant.

  13. History of receiving rTMS for any reason, as this may compromise blinding.

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: SAINT Neuromodulation System
Phase:
Study Start date:
November 01, 2025
Estimated Completion Date:
October 31, 2029

Study Description

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.

Connect with a study center

  • UMass Chan Medical School

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • The Medical School of South Carolina (MUSC)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • The Medical University of South Carolina (MUSC)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • University of Texas at Austin

    Austin 4671654, Texas 4736286 78712
    United States

    Site Not Available

  • University of Texas at Austin, Dell Medical School, Health Discovery Building

    Austin 4671654, Texas 4736286 78712
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.