SAINT in Postpartum Depression (PPD) (NCT07210255) | Clinical Trial Compass
RecruitingNot Applicable
SAINT in Postpartum Depression (PPD)
United States192 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Reproductive Women ages 18-45 at the time of consent.
✓. Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
✓. 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.
✓. If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
✓. Severe depression as measured by MADRS ≥20 at screening.
✓. A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.
✓. Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.
✓. Agree to use effective contraception in the postpartum period for the study duration.
Exclusion criteria
✕. 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.
✕. Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
✕. Participant has active psychosis per investigator assessment.
What they're measuring
1
Montgomery-Asberg Depression Rating Scale (MADRS)
Timeframe: Baseline and 5 days post-acute treatment
✕. Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
✕. 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.
✕. 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.
✕. Participant has a history of untreated or insufficiently treated sleep apnea.
✕. 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.