The Icahn School of Medicine at Mount Sinai announced on Apr. 1 that it has enrolled its first patient in a pivotal clinical trial to test whether a rapid, drug-free brain stimulation treatment can safely and quickly reduce symptoms of postpartum depression.
This study is significant because postpartum depression can affect mothers, their newborns, and families. Existing treatments like antidepressants and psychotherapy may not work quickly enough or be effective for everyone. The new therapy being tested is called SAINT, an FDA-cleared, non-invasive form of transcranial magnetic stimulation designed to deliver fast relief from depressive symptoms.
"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."
The SAINT therapy uses magnetic pulses guided by functional MRI data to target specific areas in each person's brain linked with depression. Unlike many other studies on depression treatments that require participants to have already tried medications or therapy without success, this trial allows earlier intervention by enrolling women between ages 18 and 45 who are within one year after giving birth. Participants will be randomly assigned either active SAINT treatment or a sham procedure over five days as outpatients.
Thalia Robakis, MD, PhD, Co-Principal Investigator at Mount Sinai's site study said: "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... 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 $11.6 million trial includes four research institutions: Icahn School of Medicine at Mount Sinai; Medical University of South Carolina; Dell Medical School at The University of Texas at Austin; and UMass Chan Medical School.
