Magnus Medical Enrolls First Patient in $11.6M DoD-Funded Trial of SAINT Therapy for Postpartum Depression
核心洞察
Magnus Medical (搜索) has enrolled the first patient at UMass Chan Medical School in a $11.6 million Department of Defense (搜索)-funded pivotal trial evaluating SAINT neuromodulation therapy (搜索) for postpartum depression (搜索).
The randomized controlled trial will enroll up to 192 women aged 18-45 with major depressive episodes with peripartum onset across four leading research institutions.
SAINT therapy uses brain imaging to deliver personalized magnetic stimulation over five days, with previous studies showing 79% remission rates in treatment-resistant major depression in an average of 2.6 days.
Magnus Medical (搜索) has achieved a significant milestone in postpartum depression (搜索) research with the enrollment of the first patient at University of Massachusetts Chan Medical School (搜索) (UMass Chan) in its pivotal Department of Defense (搜索)-funded clinical trial. The $11.6 million randomized controlled trial will evaluate the safety and effectiveness of SAINT neuromodulation therapy (搜索) for treating postpartum depression, marking the operational launch of this groundbreaking study.
Trial Design and Scope
The multi-center trial will enroll up to 192 women aged 18-45 years diagnosed with major depressive episode (搜索) with peripartum onset across four leading research institutions: the Medical University of South Carolina (MUSC), Dell Medical School (搜索) at The University of Texas at Austin, the Icahn School of Medicine at Mount Sinai, and UMass Chan. UMass Chan specifically will enroll 85 participants in the study.
Unlike previous SAINT studies, this trial does not require prior antidepressant or psychotherapy treatment failure. Eligible participants include women up to 12 months postpartum with moderate to severe depression, including those receiving stable antidepressant medication or psychotherapy.
SAINT Therapy Technology
SAINT neuromodulation therapy (搜索) represents the first and only FDA-cleared treatment for major depressive disorder (搜索) that uses functional MRI data to guide personalized, non-invasive neuromodulation. The therapy uses brain imaging to target mood-related regions for focused neurostimulation through a precise, individualized approach.
The treatment protocol involves participants first undergoing a magnetic resonance imaging scan of the brain to identify specific areas for individualized treatment. Patients then receive magnetic pulses to the brain in 10-minute increments for 10 sessions per day over five days in an outpatient setting. The therapy has been designated a Breakthrough Device by the FDA and is the first mental health therapy to receive innovation support from the Centers for Medicare & Medicaid Services.
Clinical Evidence and Potential Impact
Previous foundational studies have demonstrated remarkable efficacy, with 79% of patients with major depression achieving remission in an average of just 2.6 days. In a previous double-blind controlled study, SAINT brought rapid remission to almost 80% of participants with major depression.
"The study data are very promising for a subset of women with severe depression, and this therapy could provide relief for postpartum patients who are unable to find a treatment that works for them," said Dr. Kimberly A. Yonkers, the Katz Family Chair in Psychiatry and lead investigator of UMass Chan's trial site.
Addressing Critical Medical Need
Postpartum depression (搜索) affects approximately 500,000 women in the U.S. annually, with about one in eight women in the United States experiencing this condition according to the Centers for Disease Control and Prevention. Rates of postpartum depression have increased substantially since 2000, and symptoms can emerge during pregnancy or in the months after childbirth.
Current treatments, including antidepressants and psychotherapy, present significant limitations. These therapies can take weeks to work and may pose challenges for women who are breastfeeding, as antidepressants may pass to the infant during breastfeeding, causing many new mothers to be reluctant to take them.
"Postpartum depression (搜索) can be devastating. A treatment that works in days rather than weeks could be life-changing for families," Dr. Yonkers explained. "Postpartum depression is devastating, yet today's most commonly used treatments are often too slow or too burdensome for new mothers."
Research Leadership and Vision
Dr. Brandon Bentzley, co-founder and chief scientific officer of Magnus Medical (搜索), serves as the study's principal investigator. "The first patient enrolled at UMass Chan represents an important step forward in translating precision neuromodulation to a population with urgent, unmet needs," Dr. Bentzley stated.
"SAINT therapy has already shown the ability to rapidly lift depressive symptoms without systemic side effects, offering hope for a safer, faster solution. Importantly, this trial allows us to rigorously test SAINT as a non-drug intervention for postpartum depression (搜索) and to move closer to a future where mental health care is both more precise and more effective."
The work is supported by the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program, reflecting the Department of Defense (搜索)'s mission to advance innovative therapies for vulnerable populations, including new mothers in military families and beyond.