Status:
RECRUITING
SAINT in Postpartum Depression (PPD)
Lead Sponsor:
Magnus Medical
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Postpartum Depression (PPD)
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 (r...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT07210255
Start Date
November 1 2025
End Date
October 31 2029
Last Update
January 9 2026
Active Locations (4)
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1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
The Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
4
University of Texas at Austin, Dell Medical School, Health Discovery Building
Austin, Texas, United States, 78712