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NCT07210255 · ClinicalTrials.gov registry record · NA
SAINT in Postpartum Depression (PPD)
A NA study of Postpartum Depression (PPD), sponsored by Magnus Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 192
- Enrollment target
- 4
- Study locations
NCT07210255: Recruiting NA study of Postpartum Depression (PPD), sponsored by Magnus Medical.
NCT07210255 is a NA study of Postpartum Depression (PPD) that is actively recruiting participants, run by Magnus Medical. The registered enrollment target is 192 participants, below the 418-participant average among 4 other Postpartum Depression (PPD) trials with a reported enrollment target (54% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07210255, a NA study of Postpartum Depression (PPD), is actively recruiting participants, sponsored by Magnus Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 192 participants
- Enrollment target
- 4
- Study locations
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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE SAINT Neuromodulation System
- DEVICE Sham SAINT Stimulation
Study Locations (4)
Massachusetts
- UMass Chan Medical School - Worcester
New York
- Icahn School of Medicine at Mount Sinai - New York
South Carolina
- The Medical University of South Carolina (MUSC) - Charleston
Texas
- University of Texas at Austin, Dell Medical School, Health Discovery Building - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2029-10-31 |
| Phase | NA |
What NCT07210255 shows while recruiting
NCT07210255 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 418-participant average among 4 other Postpartum Depression (PPD) trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Postpartum Depression (PPD) appearing as the primary indexed condition, and to 2 interventions - of which SAINT Neuromodulation System is the first listed.
NCT07210255 reports a single indexed study location in Massachusetts, New York, South Carolina.
Frequently Asked Questions
What is clinical trial NCT07210255 about?
NCT07210255 is a clinical study titled "SAINT in Postpartum Depression (PPD)". 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 treatme...
What is the current status of trial NCT07210255?
This trial is currently recruiting. It is a NA study. The enrollment target is 192 participants. The study started on 2025-11-01. Estimated completion is 2029-10-31.
What conditions does trial NCT07210255 study?
This clinical trial studies the following conditions: Postpartum Depression (PPD).
What interventions are being tested in trial NCT07210255?
The interventions under investigation include: SAINT Neuromodulation System (DEVICE), Sham SAINT Stimulation (DEVICE).
Who is sponsoring clinical trial NCT07210255?
This trial is sponsored by Magnus Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07210255 being conducted?
This trial has 4 study locations across Massachusetts, New York, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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