Among women with postpartum depression, zuranolone was found during a phase 3, double-blind trial to improve core symptoms of depression and was well tolerated. These findings were published in JAMA Psychiatry.
Women (N=153) with postpartum depression were recruited within 6 months of giving birth at 27 centers in the United States between 2017 and 2018. Participants were randomly assigned in a 1:1 ratio to receive zuranolone 30 mg (n=77) or placebo (n=76) for 2 weeks. Through day 45, patients were assessed with use of the 17-item Hamilton Rating Scale for Depression (HAMD-17).
The mean ages of patients in the zuranolone and placebo groups were 29.3±5.4 and 27.4±5.3 years old, respectively, and 58% and 54% were White. Body mass index (BMI) was 31.1±6 and 30.3±8 kg/m2, 21% and 18% used antidepressants, and baseline HAMD-17 total scores were 28.4±2 and 28.8±2 points, respectively.
At day 15, the change from baseline in HAMD-17 scores was -17.8 points among the active treatment cohort and -13.6 points among the placebo group (P =.003). This significant difference was found to be sustained 4 weeks after treatment cessation on day 45 (least-squares mean difference, -4.1; 95% CI, -6.7 to -1.4; P =.003).
The response rate on day 15 was 72% among the zuranolone and 48% among the placebo cohorts (odds ratio [OR], 2.6; 95% CI, 1.3-5.2; P =.005), and remission rates were 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 family history had no effect on the efficacy of zuranolone compared with placebo.
Adverse events were reported by 60% of the zuranolone and 52% of the placebo recipients. The most frequent adverse events reported by participants receiving active and control treatments were 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 treatment of postpartum depression remains unclear, but there is an ongoing open-label trial to address this question.
The study authors concluded that zuranolone rapidly decreased core symptoms of depression among women experiencing postpartum depression within 6 months of giving birth.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full 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 online June 30, 2021. doi:10.1001/jamapsychiatry.2021.1559