A phase 2 clinical study of an investigational medication for treatment of women with sever postpartum depression shows promising results. UNC-CH researchers report in an article published in the medial journal The Lancet.
UNC researchers are leading the trial, and a phase 3 trial also is underway.
The treatment is called brexanolone.
“In women with severe post-partum depression, infusion of brexanolone resulted in a significant and clinically meaningful reduction in HAM-D total score, compared with placebo,” the authors report. “Our results support the rationale for targeting synaptic and extrasynaptic GABAA receptors in the development of therapies for patients with post-partum depression. A pivotal clinical programme for the investigation of brexanolone in patients with post-partum depression is in progress.”
UNC notes there are no drugs specifically indicated to treat postpartum depression (PPD), which affects an estimated 10 to 20 percent of all mothers who give birth, according to Samantha Meltzer-Brody, M.D., who is director of the Perinatal Psychiatry Program at the UNC School of Medicine, and academic principal investigator and senior author of the study.
Steve Kanes, M.D. Ph.D., Chief Medical Officer of Sage Therapeutics, is the lead author of the paper. Sage funded the research.
“The results of this trial are like nothing I’ve seen before in the treatment of postpartum depression,” Meltzer-Brody said. “It’s vital that we develop a promising treatment for postpartum depression, which is so common, yet so stigmatized.”
Twenty-one women were involved in the study with 10 receiving a 60-hour continuous intravenous dose of brexanolone. The other 11 women were given a placebo. To be eligible for the trial, women had to have severe postpartum depression, which was assessed using the Hamilton Depression Rating Scale (HAM-D). A HAM-D score of at least 26 was required for study enrollment, UNC notes.
The women treated with the drug saw a mean reduction of 21 points in their HAM-D score compared to an 8.8 point drop among those receiving the placebo. The drug was generally well tolerated with no deaths or serious adverse events or discountinuations reported, UNC added.
“In women with severe postpartum depression in the trial, infusion of brexanolone resulted in a rapid, sustained, statistically significant and clinically meaningful mean reduction in the HAM-D total score,” Meltzer-Brody said. “A 21-point reduction is not only meaningful in a clinical setting; it’s very promising in terms of potential drug development.”
The full report is available at: