NCT07210255

SAINT in Postpartum Depression (PPD)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Magnus Medical · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. A blinded phase where participants will be randomized to receive either 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo). 2. After the blinded phase, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they may be eligible to receive 1 course of active SAINT treatment. (5 days). Total study duration for each participant is approximately 7.5 months.

Conditions

• Postpartum Depression (PPD)

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2029-04-30
• Completion: 2029-10-31
• First posted: 2025-10-07
• Last updated: 2026-03-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study