RecruitingNot ApplicableNCT07210255

SAINT in Postpartum Depression (PPD)

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

Sponsor

Magnus Medical

Enrollment

192 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Postpartum Depression (PPD)

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 six months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to six months. The trial's main goal is to see if SAINT leads to rapid improvement in depression, while also evaluating its safety, durability of benefit, and impact on mother-infant bonding.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria9

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.
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.
Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.

Exclusion Criteria13

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.
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.
Any untreated major somatic illness such as hypertension/cardiovascular disease/diabetes/endocrine disorders etc.
Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).
Contraindications to MRI (e.g., ferromagnetic metal in their body).
Currently pregnant.
History of receiving rTMS for any reason, as this may compromise blinding.

Interventions

DEVICESAINT Neuromodulation System

SAINT will be delivered via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total sessions over 5 days) of SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be administered at 90% of the participant's resting motor threshold, with depth correction applied to adjust for the measured distance between the scalp and cortical surface. The stimulation target, the L-DLPFC, will be identified and localized by the study investigator using the Localite neuronavigation system.

DEVICESham SAINT Stimulation

Sham stimulation will be delivered using the MagVenture MagPro X100 TMS system with the Cool-B65 A/P coil and targeted to the L-DLPFC. The stimulation paradigm will be identical to the active SAINT stimulation with the exception that active stimulation will not be delivered.