Mount Sinai Begins Enrollment in Study of Neuromodulation Therapy for Postpartum Depression

The Icahn School of Medicine at Mount Sinai is now actively enrolling patients in a U.S. Department of Defense-funded pivotal clinical trial to evaluate whether a fast-acting, drug-free brain stimulation therapy can safely and quickly relieve postpartum depression symptoms.

The randomized controlled trial tests whether SAINT—a U.S. Food and Drug Administration-cleared, non-invasive treatment for major depressive disorder (MDD)—can deliver rapid, safe, and durable symptom relief for women suffering from depression after childbirth. Magnus Medical’s SAINT neuromodulation therapy was commercially launched in April 2024 after clinical studies demonstrated rapid, robust symptom relief and remission in people with treatment-resistant MDD.

Mount Sinai, which is considered a leading center for psychiatric innovation and a pioneer in depression research and treatment, is one of four U.S. sites selected to participate in the $11.6 million study.

“Postpartum depression can have profound negative consequences for not only mothers but for their newborn children and families,” said Veerle Bergink, M.D., Ph.D., director of the Women’s Mental Health Center at Mount Sinai and co-principal study investigator at the Mount Sinai site. “Current treatments, including antidepressants and psychotherapy, are often too slow to act and may not be effective for all women, which underscores the need for faster, more effective and targeted therapies. We are eager to find out whether this new, non-invasive and non-drug treatment can provide meaningful relief to women who are suffering depression during a particularly vulnerable period following childbirth.” 

SAINT is an advanced form of transcranial magnetic stimulation—a noninvasive treatment that uses magnetic pulses to stimulate specific brain regions involved in depression—to help improve mood by restoring healthy brain activity patterns. Using functional MRI data, stimulation is precisely targeted to brain regions identified through each person’s unique brain connectivity patterns.

Unlike many depression studies, this trial does not require participants to have failed antidepressants or psychotherapy, broadening access to earlier intervention. Mount Sinai is actively enrolling women aged of 18 and 45 who are within 12 months postpartum and are currently experiencing Postpartum Depression symptoms. Participants are randomly assigned to receive either active SAINT treatment or a sham (inactive) treatment during the first phase. Treatment takes place over an accelerated five-day schedule in an outpatient setting. Participants will receive 10 daily treatment sessions, with each stimulation session lasting approximately 10 minutes.

“At the Mount Sinai Women’s Mental Health Center, our team of mental health specialists have the reproductive psychiatry expertise needed to carefully and holistically approach the needs of mother and child immediately following birth,” said Thalia Robakis, M.D., Ph.D., co-principal investigator of the Mount Sinai site study and co-director of the Women’s Mental Health Center at Mount Sinai. “To improve the care we provide, we remain at the forefront of advancing our knowledge through research and education, so we are proud to offer New Yorkers the opportunity to take part in research that could improve how depression is treated during the postpartum period.”

The four leading research institutions involved in the trial, in addition to the Icahn School of Medicine are: the Medical University of South Carolina, Dell Medical School at The University of Texas at Austin, and UMass Chan Medical School.

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across seven hospitals, more than 400 outpatient practices, over 600 research and clinical labs, a school of nursing, and a school of medicine and graduate education. Mount Sinai advances health by discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities through high-quality care.

Through the integration of its hospitals, labs, and schools, Mount Sinai offers healthcare solutions from birth through geriatrics, leveraging approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 9,000 primary and specialty care physicians and 10 free-standing joint-venture centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida. Hospitals within the System are consistently ranked by Newsweek’s “The World’s Best Smart Hospitals, Best in State Hospitals, World Best Hospitals and Best Specialty Hospitals” and by U.S. News & World Report’s “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report “Best Hospitals” Honor Roll for 2025-2026.