The Icahn School of Medicine at Mount Sinai today announced the enrollment of its first patient 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 symptoms of postpartum depression.
Mount Sinai is now actively enrolling patients in a randomized controlled trial to test whether SAINT ®, an FDA-cleared, non-invasive treatment for major depressive disorder (MDD), can deliver rapid, safe and durable symptom relief for women experiencing depression following childbirth. Magnus Medical's SAINT ® neuromodulation therapy was commercially launched in April 2024 following clinical studies demonstrating rapid, robust symptom relief and remission in people with treatment-resistant major depressive disorder.
Mount Sinai, one of the nation's leading centers for psychiatric innovation and a recognized pioneer in depression research and treatment, is one of four sites nationwide 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, MD, PhD, Director of the Women's Mental Health Center at Mount Sinai and Co-Principal Investigator of the study 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 areas of the brain 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 between the ages of 18 and 45 who are within 12 months postpartum and are currently experiencing symptoms of Postpartum Depression. 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 5-day schedule in an outpatient setting. Participants will receive ten treatment sessions per day, with each stimulation session lasting approximately 10 minutes.
To learn more details about the study at Mount Sinai, please visit: SAINT in Postpartum Depression (PPD) | Mount Sinai - New York
"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, MD, PhD, 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 on the forefront of advancing our knowledge through research and education, so 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. Additional information regarding trial enrollment at the four leading research institutions may be found at learn.magnusmedical.com/ppd-trial/.
The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of War, in the amount of $11,619,193, through the Peer Reviewed Medical Research Program under Award No. HT9425-25-1-0222. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of War.
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