RecruitingNot ApplicableNCT07210255

SAINT in Postpartum Depression (PPD)

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

Sponsor

Magnus Medical

Enrollment

192 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Postpartum Depression (PPD)

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests a fast-acting brain stimulation therapy called SAINT (Stanford Accelerated Intelligent Neuromodulation Therapy) — a type of transcranial magnetic stimulation (TMS) — for women with severe postpartum depression. Instead of weeks of daily sessions, SAINT is delivered intensively over just a few days. **You may be eligible if...** - You are a woman between 18 and 45 years old - You are within 12 months of giving birth - You have been diagnosed with severe major depression that started during or after pregnancy (MADRS score ≥ 20) - If you are on antidepressants or in therapy, your treatment has been stable for at least 30 days - You are medically cleared for TMS treatment **You may NOT be eligible if...** - Your depression includes psychotic features - You are not safe for TMS (e.g., metal implants in the head, certain neurological conditions) - You are outside the 0–12 month postpartum window Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESAINT 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.

DEVICESham 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.