Actively Recruiting
SAINT in Postpartum Depression (PPD)
Led by Magnus Medical · Updated on 2026-05-14
192
Participants Needed
4
Research Sites
208 weeks
Total Duration
On this page
Sponsors
M
Magnus Medical
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
SAINT in Postpartum Depression (PPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years at the time of consent
- Diagnosis of non-psychotic major depressive episode with onset around childbirth
- Within 0 to 12 months postpartum at screening and at 5-day post-treatment visit
- Stable antidepressant medication and/or psychotherapy regimen for at least 30 days if currently receiving treatment
- Severe depression with Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or higher at screening
- Good candidate for repetitive transcranial magnetic stimulation as determined by a physician
- Ability to give informed consent and proficiency in English
- Agreement to use effective contraception during the study
- Willingness and ability to comply with study procedures, assessments, visits, and availability for the study duration
You will not qualify if you...
- Suicide attempt in the last 6 months or suicidal ideation with intent at enrollment
- High suicidal ideation score (6) on MADRS item 10 at screening
- Active psychosis
- Primary diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or obsessive-compulsive disorder
- Active eating disorder or substance use disorder in past 6 months, or positive urine drug screen deemed exclusionary
- Use of high-dose benzodiazepines or medications interfering with TMS treatment
- History of untreated or insufficiently treated sleep apnea
- Significant neurological diseases such as developmental disability, dementia, Parkinson's, Huntington's, brain tumor, seizures, subdural hematoma, multiple sclerosis, or head trauma
- Untreated major medical illnesses like hypertension, cardiovascular disease, diabetes, or endocrine disorders
- Contraindications to rTMS such as metal in head, history of seizure, or brain lesion
- Contraindications to MRI such as ferromagnetic metal in body
- Currently pregnant
- Previous treatment with rTMS that may affect blinding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
3
The Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
4
University of Texas at Austin, Dell Medical School, Health Discovery Building
Austin, Texas, United States, 78712
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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