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RECRUITING
NCT07210255
NA

SAINT in Postpartum Depression (PPD)

Sponsor: Magnus Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2025-11-01

Completion Date

2029-10-31

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

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.

Locations (4)

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