Sponsor:
Magnus Medical
Code:
NCT07210255
Conditions
Postpartum Depression (PPD)
Eligibility Criteria
Sex: Female
Age: 18 - 45
Healthy Volunteers: Not accepted
Interventions
SAINT Neuromodulation System
Sham SAINT Stimulation
Brief summary:
Conditions
Postpartum Depression (PPD)
Study ID
NCT07210255
Start date
Nov 1, 2025
Status verified date
May, 2026
Completion date
Oct 31, 2029
Anticipated
Primary completion date
Apr 30, 2029
Anticipated
Eligibility Criteria
Sex: Female
Age: 18 - 45
Healthy Volunteers: Not accepted
Enrollment
192 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: Active SAINT Stimulation
sham comparator: Sham SAINT Stimulation
Interventions
SAINT Neuromodulation System
Sham SAINT Stimulation
Primary outcome measure
Locations
UMass Chan Medical School
Recruiting
Worcester, Massachusetts, United States, 01655
Contacts
Principal Investigator:
Kimberly Yonkers, MD
Icahn School of Medicine at Mount Sinai
Recruiting
New York, New York, United States, 10029
Contacts
Principal Investigator:
Thalia Robakis, MD, PhD
The Medical University of South Carolina (MUSC)
Recruiting
Charleston, South Carolina, United States, 29425
Contacts
Principal Investigator:
Connie Guille, MD
University of Texas at Austin, Dell Medical School, Health Discovery Building
Recruiting
Austin, Texas, United States, 78712
Contacts
Principal Investigator:
Jeffrey Newport, MD, MS, MDiv
Sponsor
Magnus Medical
Last update posted
May 14, 2026
Last verified
May, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by Magnus Medical on 2026-05-14.