SAINT in Postpartum Depression (PPD)
- NCT ID
- NCT07210255
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- Magnus Medical
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 192 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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.
Study locations
4 study locations are listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Massachusetts, United States: 1
- New York, United States: 1
- South Carolina, United States: 1
- Texas, United States: 1
Sample of listed locations
- UMass Chan Medical School — Worcester, Massachusetts, 01655, United States — Site recruitment status not specified in the registry data
- Icahn School of Medicine at Mount Sinai — New York, New York, 10029, United States — Site recruitment status not specified in the registry data
- The Medical University of South Carolina (MUSC) — Charleston, South Carolina, 29425, United States — Site recruitment status not specified in the registry data
- University of Texas at Austin, Dell Medical School, Health Discovery Building — Austin, Texas, 78712, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- November 1, 2025
- Primary completion date
- April 30, 2029
- First posted
- October 7, 2025
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07210255
- Registry last updated
- September 17, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07210255 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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