ZURZUVAE™ (zuranolone) demonstrated rapid improvement
of postpartum depression (PPD) symptoms1,2

Statistically significant improvement vs placebo at Day 15
with treatment effect seen as early as
Day 31

LS mean change from baseline in HAMD-17 total score across the study period1,2



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Statistically significant improvements in depressive symptoms were observed for the primary and all key secondary endpoints1,2

Mean baseline HAMD-17 scores (SD): ZURZUVAE 50 mg, 28.6 (2.49); Placebo, 28.8 (2.34).1
HAMD-17, 17-item Hamilton Depression Rating Scale; LS, least squares; SD, standard deviation.
For more information on the HAMD-17, please see the study design below.

ZURZUVAE clinical trial design

The pivotal SKYLARK phase 3 study evaluated the efficacy and safety of ZURZUVAE in women with PPD1,2

  • SKYLARK was a 6-week, randomized, placebo-controlled, double-blind, multicenter study1
  • ZURZUVAE 50 mg or placebo was taken orally once daily in the evening with fat-containing food for 14 days, after which patients were off ZURZUVAE or placebo and were followed through Day 451
  • Concomitant use of existing oral antidepressants was allowed during the treatment course for patients taking stable oral antidepressants for at least 30 days before baseline1
    • Baseline use of stable oral antidepressants was reported in 15% of patients. The remaining 85% received ZURZUVAE or placebo as monotherapy1
  • The study included 195 adult patients with PPD in the full analysis set (N=98 ZURZUVAE 50 mg and N=97 placebo) who met the DSM-5 criteria for a major depressive episode with onset of symptoms in the third trimester or within 4 weeks of delivery and had a baseline HAMD-17 total score of ≥261
    • HAMD-17 (Hamilton Rating Scale for Depression) is a 17-item, clinician-rated scale used to assess severity of depressive symptoms3
    • Scores on the HAMD-17 range from 0 to 52; a score of 17–23 indicates moderate depression and a score of ≥24 indicates severe depression3,4
  • The primary endpoint was change from baseline in depressive symptoms as measured by the HAMD-17 total score at Day 151
  • The key secondary endpoints included change from baseline in HAMD-17 total score at Days 3, 28, and 451

References: 1. ZURZUVAE Prescribing Information. Cambridge, MA: Biogen and Sage Therapeutics, Inc; 11/2023. 2. Deligiannidis KM, Meltzer-Brody S, Maximos B, et al. Zuranolone for the Treatment of Postpartum Depression. Am J Psych. 2023;180(9):668-675. 3. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psych. 1960;23:56-62. 4. Zimmerman M, Martinez JH, Young D, et al. Severity classification on the Hamilton depression rating scale. J Affect Disord. 2013;150:384-388.