At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.
In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).
Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
“This newer approach, transcutaneous auricular VNS, is non-invasive, is well tolerated, and has shown initial efficacy in major depression in men and women,” she said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
Potential alternative to meds
“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.
Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.
Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.
Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.
“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.
The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.
The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.
By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.
In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.
The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.
Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”
Dr. Clayton, who was not involved with the research, also noted the “pretty high” response and remission rates.
“So, I think this does have promise, and it would be worth doing a study where you look at placebo versus this treatment,” she said.
“Many women are fearful of taking medicines postpartum, even peripartum, unless they have had pre-existing severe depression. This is not a medicine, and it sounds like it could be useful even in people who are pregnant, although it’s harder to do studies in pregnant women,” Dr. Clayton added.
The study was funded by Nesos Corporation. Dr. Deligiannidis received contracted research funds from Nesos Corporation to conduct this study. She also serves as a consultant to Sage Therapeutics, Brii Biosciences, and GH Research. Dr. Clayton reports financial relationships with Dare Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, AbbVie, Brii Biosciences, Fabre-Kramer, Field Trip Health, Mind Cure Health, Ovoca Bio, PureTech Health, S1 Biopharma, Takeda/Lundbeck, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire, Guilford Publications, Euthymics Bioscience, and Mediflix.
A version of this article first appeared on Medscape.com.