NCT07210255 · Magnus Medical
SAINT in Postpartum Depression (PPD)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
- Participant has active psychosis per investigator assessment.
- Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
- 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.
- 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.
- Participant has a history of untreated or insufficiently treated sleep apnea.
- 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.
- Any untreated major somatic illness such as hypertension/cardiovascular disease/diabetes/endocrine disorders etc.
- Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).
- Contraindications to MRI (e.g., ferromagnetic metal in their body).
- Currently pregnant.
- History of receiving rTMS for any reason, as this may compromise blinding.
Where
- Worcester, Massachusetts
- New York, New York
- Charleston, South Carolina
- Austin, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations