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SAINT in Postpartum Depression (PPD)

Recruiting

A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression

Who can join

Ages 18 to 45 · Women

Full eligibility criteria
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 as assessed through the Quick Structured Clinical Interview for DSM-5.
3. 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.
4. If currently taking an antidepressant medication and/or receiving psychotherapy must be 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) as determined by a physician.
7. Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.
8. Agree to use effective contraception in the postpartum period for the study duration.
9. Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.

Exclusion Criteria:

1. Participant has attempted suicide in the last 6 months and/or expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.
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 6 months 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 would interfere 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 developmental disability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
9. Any untreated major somatic illness such as hypertension/cardiovascular disease/diabetes/endocrine disorders etc.
10. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain 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.

About the study

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, 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.

What is being tested

Sponsor: Magnus Medical · Participants: 192 · Started: Nov 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07210255

Locations in the U.S.

MassachusettsUMass Chan Medical School, Worcester
New YorkIcahn School of Medicine at Mount Sinai, New York
South CarolinaThe Medical University of South Carolina (MUSC), Charleston
TexasUniversity of Texas at Austin, Dell Medical School, Health Discovery Building, Austin

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.