The Icahn School of Medicine at Mount Sinai announced enrollment in a U.S. Department of Defense-funded pivotal clinical trial evaluating whether a fast-acting, drug-free brain stimulation therapy can safely and quickly relieve symptoms of postpartum depression. The $11.6 million study is being conducted at four leading research institutions: Mount Sinai, the Medical University of South Carolina, Dell Medical School at The University of Texas at Austin, and UMass Chan Medical School.
Mount Sinai is actively enrolling women between the ages of 18 and 45 who are within 12 months postpartum and currently experiencing symptoms of postpartum depression. The trial tests whether SAINT, an FDA-cleared, non-invasive treatment for major depressive disorder, can deliver rapid, safe and durable symptom relief. 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. Using functional MRI data, stimulation is precisely targeted to brain regions identified through each person’s unique brain connectivity patterns.
Trial Design and Advantages
Unlike many depression studies, this trial does not require participants to have failed antidepressants or psychotherapy, broadening access to earlier intervention. Participants are randomly assigned to receive either active SAINT treatment or a sham (inactive) treatment. Treatment takes place over an accelerated 5-day schedule in an outpatient setting, with participants receiving ten treatment sessions per day lasting approximately 10 minutes each. According to Veerle Bergink, MD, PhD, Director of the Women’s Mental Health Center at Mount Sinai, “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.”
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.newswise.com/articles/mount-sinai-enrolling-patients-in-dod-funded-clinical-trial-of-drug-free-neuromodulation-therapy-for-postpartum-depression/?sc=rsmn