SAINT for postpartum depression

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

This project will test whether SAINT, a fast-acting form of noninvasive brain stimulation, can quickly reduce depression symptoms in women within 12 months after giving birth whose symptoms have not improved with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Magnus Medical (industry)
• Locations: 4 sites (Worcester, Massachusetts and 3 other locations)
• Trial ID: NCT07210255 on ClinicalTrials.gov

What this trial studies

This is a multi-site, randomized, sham-controlled trial comparing the SAINT accelerated rTMS protocol with a sham procedure in women 0–12 months postpartum with moderate-to-severe depression. SAINT combines accelerated intermittent theta-burst stimulation with individualized functional connectivity–based targeting and is delivered over a short course of treatment. The trial plans to enroll 192 participants across three academic sites and will track symptom changes for up to 12 months. The primary outcome is reduction in depression severity compared with sham, with additional follow-ups to assess durability and safety.

Who should consider this trial

Good fit: Reproductive-age women (18–45) within 0–12 months postpartum who meet criteria for a non-psychotic major depressive episode with MADRS ≥20, have not improved with standard care, are medically appropriate for rTMS, and can comply with study procedures are ideal candidates.

Not a fit: Women outside the 0–12 month postpartum window, those with psychotic depression or significant contraindications to rTMS, or those with milder depression (MADRS <20) are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, SAINT could provide rapid relief from postpartum depression symptoms, helping new mothers recover faster and improve bonding and daily functioning.

How similar studies have performed: SAINT produced very high remission rates (reported 80–90%) in prior treatment-resistant depression cohorts and is FDA-cleared for MDD after failed medications, but its use specifically in postpartum depression is still novel and less well-studied.

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.

Where this trial is running

Worcester, Massachusetts and 3 other locations

• UMass Chan Medical School — Worcester, Massachusetts, United States (RECRUITING)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
• The Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (RECRUITING)
• University of Texas at Austin, Dell Medical School, Health Discovery Building — Austin, Texas, United States (RECRUITING)

Conditions: Postpartum Depression, SAINT, Stanford Accelerated Intelligent Neuromodulation Therapy, Repetitive Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation, Noninvasive Brain Stimulation, Postpartum depression, Neuromodulation