SAINT in Postpartum Depression (PPD)

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
Magnus Medical
Study ID
NCT07210255
Status
Recruiting
Apply to this trial

Conditions

  • Postpartum Depression (PPD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • SAINT Neuromodulation System — DEVICE
    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.
  • Sham SAINT Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
May 2026
Primary completion
Apr 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active SAINT Stimulation
    Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
  • Sham Comparator: Sham SAINT Stimulation
    Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and 5 days post-acute treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
UMass Chan Medical SchoolWorcesterMassachusetts01655
Erin Hanzlik
[email protected]
774.370.8613
Sherry Stumpo
[email protected]
508-334-1055
Kimberly Yonkers, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Francesca Rutherford
[email protected]
646-853-3316
Carolina Jimenez
[email protected]
646-493-1684
Thalia Robakis, MD, PhD (PRINCIPAL_INVESTIGATOR)
Veerle Bergink, MD, PhD (PRINCIPAL_INVESTIGATOR)
The Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425
Christina Marsicano
[email protected]
843-608-8593
Connie Guille, MD (PRINCIPAL_INVESTIGATOR)
University of Texas at Austin, Dell Medical School, Health Discovery BuildingAustinTexas78712
Ambreen Rana
[email protected]
512-766-6209
Jeffrey Newport, MD, MS, MDiv (PRINCIPAL_INVESTIGATOR)

Find similar trials in Worcester, MA

By research site
UMass Chan Medical School· Worcester, MAIcahn School of Medicine at Mount Sinai· New York, NYThe Medical University of South Carolina (MUSC)· Charleston, SCUniversity of Texas at Austin, Dell Medical School, Health Discovery Building· Austin, TX

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