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SAINT in Postpartum Depression (PPD)

A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "It will enroll 192 women within 12 months postpartum who are experiencing depression, and will track their progress for up to 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether SAINT, a fast form of treatment that uses magnetic pulses to stimulate the brain, reduces depression more than a sham (inactive) treatment. It is for women ages 18–45 with depression within 12 months after giving birth. The study will follow participants for up to 12 months.

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, 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a woman age 18–45 when you agree to join.
  • Have major depression that began during pregnancy or soon after birth, without psychosis (trouble knowing what is real).
  • Be within 12 months after giving birth at screening and at the visit 5 days after treatment.
  • Have severe depression, with a score of at least 20 on the study’s depression rating scale.
  • If you take depression medicine or get talk therapy, have had no changes to that treatment for at least 30 days before joining.
  • Have a doctor confirm that magnetic brain stimulation (rTMS) is suitable for you.
  • Be able to give informed consent, understand English, and complete all study visits and tasks.
  • Agree to use effective birth control for the length of the study.

Who can't join

  • Have attempted suicide in the past 6 months, have suicidal thoughts with intent to act, or have the highest suicide-thought rating on the study scale.
  • Have active psychosis, or have ever had a primary diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or obsessive-compulsive disorder.
  • Have an active eating disorder, a substance use disorder in the past 6 months, or a urine drug test result that the study doctor says rules out joining.
  • Use certain medicines that interfere with magnetic brain stimulation, including benzodiazepines above the study’s dose or use limits.
  • Have untreated or poorly treated sleep apnea (breathing that stops and starts during sleep), or a major untreated illness such as heart disease or diabetes.
  • Have a major brain or nerve condition, such as dementia, Parkinson’s disease, a brain tumor, seizures, multiple sclerosis, or a serious past head injury.
  • Cannot safely receive magnetic brain stimulation or an MRI scan, for example because of certain metal in your head or body.
  • Are currently pregnant or have ever received magnetic brain stimulation (rTMS) for any reason.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (4)

MA

NY

SC

TX