SAINT in Postpartum Depression (PPD)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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, 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.
Eligibility
Primary outcome measure(s)
- 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. — Baseline and 5 days post-acute treatment
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.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| The Medical University of South Carolina (MUSC) | Charleston | South Carolina | Recruiting |
| University of Texas at Austin, Dell Medical School, Health Discovery Building | Austin | Texas | Recruiting |
More Magnus Medical trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07210255 on ClinicalTrials.gov ↗ ← All trials in the USA