SAINT in Postpartum Depression (PPD)
Key facts
- Who runs it
- Magnus Medical
- Where
- Austin, Charleston, New York, and Worcester, United StatesSee the 4 sites
- Trial code
- Status
- Recruiting
- People taking part
- 192 people, planned
- Started
- 1 Nov 2025
- Expected to end
- 31 Oct 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- SAINT Neuromodulation System
- Sham SAINT Stimulation
- Record updated
- 28 September 2026
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
- History of receiving rTMS for any reason, as this may compromise blinding
- 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 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
- 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
- Contraindications to MRI (e.g., ferromagnetic metal in their body)
- Currently pregnant
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in United States
- University of Texas at Austin, Dell Medical School, Health Discovery BuildingAustin, United StatesContact: Ambreen RanaTaking people
- The Medical University of South Carolina (MUSC)Charleston, United StatesContact: Myranda Reppart, MPHTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Francesca RutherfordTaking people
- UMass Chan Medical SchoolWorcester, United StatesContact: Erin HanzlikTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Active SAINT StimulationExisting treatment, for comparison
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Treatment: SAINT Neuromodulation System
- Sham SAINT StimulationSham treatment, for comparison
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression
- Fit questions
- Built from NCT07210255, who can take part
- Record updated
- 28 September 2026