SAINT in Postpartum Depression (PPD)

NCT07210255 | Recruiting DMC FDA Device

• 2 other identifiers: CLN-0108CDMRP-PR240070
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Postpartum Depression (PPD)

Keywords

SAINT; Stanford Accelerated Intelligent Neuromodulation Therapy; Repetitive Transcranial Magnetic Stimulation (rTMS); Intermittent Theta Burst Stimulation (iTBS); Noninvasive Brain Stimulation; Postpartum depression; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.

  Baseline and 5 days post-acute treatment

Other Outcomes (3)

• Montgomery-Asberg Depression Rating Scale - Self Report (MADRS-S)

  Baseline, 5 days post acute treatment through 6 months (180 days) post-treatment follow-up (assessed every 14 days).

• Treatment Adherence and Acceptability Scale (TAAS)

  5-day post acute treatment visit and if applicable, 5 days post open-label treatment visit.

• Mother-to-Infant Bonding Scale (MIBS)

  Baseline, 1 month, 3 months, 6 months post-treatment

Study Arms (2)

Active SAINT Stimulation

ACTIVE COMPARATOR

Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)

Device: SAINT Neuromodulation System

Sham SAINT Stimulation

SHAM COMPARATOR

Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).

Device: Sham SAINT Stimulation

Interventions

SAINT Neuromodulation System DEVICE

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.

Also known as: SAINT NMS, SAINT

Active SAINT Stimulation

Sham SAINT Stimulation DEVICE

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.

Sham SAINT Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Magnus Medical: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (4)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

The Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

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

Austin, Texas, 78712, United States

RECRUITING

Related Publications (3)

• Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379. No abstract available.

  PMID: 29415152 BACKGROUND

• Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.

  PMID: 34711062 BACKGROUND

• Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

  PMID: 32252538 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study monitors, SAINT treaters, Research coordinators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multisite, randomized controlled trial. This study has two phases, a blinded/acute phase in which participants are randomized to receive either 5 days of active or sham SAINT and a follow-up phase in which all participants will be followed for 6 months and may be eligible to receive 1 course of open-label active SAINT (5 days).

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)