Among females with postpartum depression, zuranolone was located in the course of a phase 3, double-blind trial to increase core symptoms of depression and was properly tolerated. These findings had been published in JAMA Psychiatry.
Women (N=153) with postpartum depression had been recruited inside 6 months of providing birth at 27 centers in the United States involving 2017 and 2018. Participants had been randomly assigned in a 1:1 ratio to obtain zuranolone 30 mg (n=77) or placebo (n=76) for 2 weeks. Through day 45, patients had been assessed with use of the 17-item Hamilton Rating Scale for Depression (HAMD-17).
The imply ages of patients in the zuranolone and placebo groups had been 29.3±5.4 and 27.4±5.3 years old, respectively, and 58% and 54% had been White. Body mass index (BMI) was 31.1±6 and 30.3±8 kg/m2, 21% and 18% made use of antidepressants, and baseline HAMD-17 total scores had been 28.4±2 and 28.8±2 points, respectively.
At day 15, the adjust from baseline in HAMD-17 scores was -17.8 points amongst the active therapy cohort and -13.6 points amongst the placebo group (P =.003). This important distinction was located to be sustained 4 weeks immediately after therapy cessation on day 45 (least-squares imply distinction, -4.1 95% CI, -6.7 to -1.4 P =.003).
The response price on day 15 was 72% amongst the zuranolone and 48% amongst the placebo cohorts (odds ratio [OR], 2.6 95% CI, 1.3-5.2 P =.005), and remission prices had been 45% and 23%, respectively (OR, 2.5 95% CI, 1.2-5.2 P =.01).
Stratifying patients into subgroups of age, ethnicity, antidepressant use, BMI, onset of postpartum depression, or loved ones history had no impact on the efficacy of zuranolone compared with placebo.
Adverse events had been reported by 60% of the zuranolone and 52% of the placebo recipients. The most frequent adverse events reported by participants getting active and handle therapies had been somnolence (15% vs 11%), headache (9% vs 12%), dizziness (8% vs 6%), upper respiratory tract infection (8% vs 1%), and diarrhea (6% vs 3%), respectively.
The longer-term efficacy of zuranolone for the therapy of postpartum depression remains unclear, but there is an ongoing open-label trial to address this query.
The study authors concluded that zuranolone swiftly decreased core symptoms of depression amongst females experiencing postpartum depression inside 6 months of providing birth.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device organizations. Please see the original reference for a complete list of authors’ disclosures.
Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, et al. Effect of zuranolone vs placebo in postpartum depression: a randomized clinical trial. JAMA Psychiatry. Published on the web June 30, 2021. doi:10.1001/jamapsychiatry.2021.1559