New brain zaps could lift postpartum depression in days
NCT ID NCT07210255
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tests whether a quick form of brain stimulation called SAINT can reduce symptoms of postpartum depression better than a fake treatment. It will include 192 women who are up to 12 months after giving birth and whose depression hasn't improved with standard care. The main goal is to see if SAINT leads to a meaningful drop in depression severity within just a few days.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Oct 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Postpartum depression (PPD) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
-
The Medical University of South Carolina (MUSC)
RECRUITINGCharleston, South Carolina, 29425, United States
-
UMass Chan Medical School
RECRUITINGWorcester, Massachusetts, 01655, United States
-
University of Texas at Austin, Dell Medical School, Health Discovery Building
RECRUITINGAustin, Texas, 78712, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill ease severe postpartum depression?
- Could more doula visits ease postpartum depression?
- A healing hand: could Doula-Midwife teams transform postpartum recovery for NICU moms?
- Magnetic pulses to the brain: a Drug-Free hope for peripartum depression?
- Can a wearable light device lift the fog of postpartum depression?
- Can a Three-Day pill ease postpartum depression?