AUSTIN, Texas — A large, Department of Defense-funded clinical trial is now underway to determine whether a fast-acting, drug-free brain stimulation therapy can safely and quickly relieve symptoms of postpartum depression during the critical weeks and months after childbirth. The University of Texas at Austin is one of four sites nationwide selected to participate in the $11.6 million study.
This trial is led nationally by Magnus Medical and tests SAINT neuromodulation, a personalized brain stimulation therapy that is Food and Drug Administration-cleared for major depressive disorder. In foundational studies of treatment-resistant depression, 79% of patients achieved remission in an average of just 2.6 days. This randomized controlled trial will evaluate whether the same approach can be safely applied to postpartum depression.
Unlike many depression studies, this trial does not require participants to have failed prior antidepressant or psychotherapy treatment.
The study is supported through the Department of Defense’s Peer Reviewed Medical Research Program. UT Austin’s Dell Medical School joins the Medical University of South Carolina, the Icahn School of Medicine at Mount Sinai and the University of Massachusetts Chan Medical School as one of four participating research institutions.
“Postpartum depression is both common and profoundly disruptive, affecting not only mothers but their infants and families,” said Jeffrey Newport, M.D., site principal investigator at UT Austin and a professor in the Department of Psychiatry and Behavioral Sciences at Dell Medical School. “This study is designed to test whether a noninvasive, nondrug treatment can provide meaningful relief much more quickly than current options allow.”
Postpartum depression affects about 500,000 women in the United States each year, with rates increasing substantially since 2000. Existing treatments, including antidepressant medications and psychotherapy, may take weeks to show benefit and are not effective for all patients. Some medications may also be transferred during breastfeeding, leading many new mothers to delay or avoid treatment.
“This study gives patients in Central Texas the opportunity to take part in research that could improve how depression is treated during a particularly vulnerable period after childbirth,” Newport said.
The trial will enroll up to 192 women ages 18-45 who are experiencing a major depressive episode with peripartum onset. Enrollment at UT Austin is underway. Those interested can visit this website to submit an interest form, and study staff will reach out with more information about eligibility.
This work is supported by the Assistant Secretary of Defense for Health Affairs, endorsed by the Department of Defense, in the amount of $11,619,193.00 through the Peer Reviewed Medical Research Program under Award Number HT94252510222. Opinions, interpretations, conclusions, and recommendations are those of the author(s) and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.