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New brain zaps could lift postpartum depression in days

NCT ID NCT07210255

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    New York, New York, 10029, United States

  • The Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • UMass Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Texas at Austin, Dell Medical School, Health Discovery Building

    RECRUITING

    Austin, Texas, 78712, United States

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Other studies related to the condition(s) this trial covers.