An interventional study of SAINT Neuromodulation System and Sham SAINT Stimulation in Postpartum Depression (PPD), sponsored by Magnus Medical. Recruiting at 4 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Magnus Medical · Not applicable, Interventional, and Treatment
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.
SAINT combines an accelerated rTMS stimulation protocol with individualized functional connectivity (FC)-based brain targeting. It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment. SAINT is FDA cleared for the treatment of major depressive disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
This is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in women with PPD. 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:
Total study duration for each participant is approximately 7.5 months.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 192 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Magnus Medical is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Device: SAINT Neuromodulation System
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).
Device: Sham SAINT Stimulation
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
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.
The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms.
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.
Time frame: Baseline and 5 days post-acute treatment
The durability of SAINT's effects on symptom severity will be assessed with the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) using Kaplan-Meier survival curves and Cox proportional hazards models.
Durability of treatment will be assessed from immediately after treatment through six months (180 days) using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S). The MADRS-S consists of 9 questions, each scored from 0 to 3, with a total score range of 0-27. Higher scores indicate greater depressive symptom severity, while lower scores indicate improvement in symptoms.
Time frame: Baseline, 5 days post acute treatment through 6 months (180 days) post-treatment follow-up (assessed every 14 days).
Tolerability will be assessed at the 5-day post-acute treatment visit and, if the participant receives open-label SAINT, again at the 5-day post treatment follow-up visit using the Treatment Adherence and Acceptability Scale (TAAS)
Treatment acceptance and adherence will be assessed using the 10-item Treatment Acceptance and Adherence Scale (TAAS). Each item is rated from 1 to 7, for a total score range of 10 to 70. Higher scores indicate greater treatment acceptance and adherence, while lower scores indicate poorer acceptance and adherence.
Time frame: 5-day post acute treatment visit and if applicable, 5 days post open-label treatment visit.
The impact on maternal functioning/bonding will be assessed using the Mother-to-Infant Bonding Scale (MIBS).
An 8-item self-report questionnaire used to assess the early emotional bond between a mother and her infant. Each item is scored 0-3 with a score ranging from 0-24. Higher scores reflect greater bonding difficulties; lower scores reflect more positive bonding.
Time frame: Baseline, 1 month, 3 months, 6 months post-treatment
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality concerns. Aggregate study results will be made publicly available on ClinicalTrials.gov and through publications.
Started Nov 2025 (actual). Primary completion is estimated for Apr 2029, 41 months after the start.
Of 262 interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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