Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
192 participants
INTERVENTIONAL
2025-11-01
2029-10-31
Brief Summary
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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.
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Detailed Description
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This is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women who are non-responsive to standard of care treatment. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in PPD among women unresponsive to standard care. Unlike traditional treatments, SAINT is designed to provide rapid relief from depressive symptoms, potentially within just a few days. The rationale for this study is based on the need for a faster, more effective treatment option that can quickly stabilize the mental health of new mothers, allowing them to better care for their infants and themselves.
This study will primarily benefit women who have recently given birth and are struggling with a postpartum depression. These women often face intense emotional distress that can interfere with their ability to bond with their newborns and manage daily responsibilities. By offering a quicker route to recovery, SAINT has the potential to restore these mothers' mental health, enabling them to fully engage in their new role as parents. The study also aims to include a diverse population, ensuring that the benefits of SAINT are generalizable.
There are two phases in this study:
1. A blinded phase where participants will be randomized to receive 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo) treatment.
2. After the acute treatment, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they will be offered 1 course of active SAINT treatment. (5 days).
Total study duration for each participant is approximately 7.5 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active SAINT Stimulation
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
SAINT 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.
Sham SAINT Stimulation
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).
Sham 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.
Interventions
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SAINT 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.
Sham 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
FEMALE
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
Magnus Medical
INDUSTRY
Responsible Party
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Locations
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UMass Chan Medical School
Worcester, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
University of Texas at Austin, Dell Medical School, Health Discovery Building
Austin, Texas, United States
Countries
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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CDMRP-PR240070
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CLN-0108
Identifier Type: -
Identifier Source: org_study_id
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