ZURANOLONE (ZURZUVAE®)



















Zuranolone vs Placebo for Postpartum Depression, (2022) [ClinicalTrials.gov]
  • The trial enrolled 200 women with a major depressive episode beginning in the third trimester and up to 4 weeks after delivery
Main inclusion criteria
  • Major depressive episode beginning in the 3rd trimester or up to 4 weeks postpartum
  • Agree to stop breastfeeding during treatment and for 7 days after
  • ≤ 12 months postpartum
Main exclusion criteria
  • Suicidal
  • Active psychosis
  • History of seizure
  • Bipolar or schizophrenia
  • History of sleep apnea
Baseline characteristics
  • Average age 30 years
  • Baseline antidepressant use - 15%
  • Baseline 17-item HAMD score - 28.7
Randomized treatment groups
  • Group 1 (98 patients): Zuranolone 50 mg once daily for 14 days
  • Group 2 (97 patients): Placebo
  • Drug dose could be reduced to 40 mg based on tolerability
  • Patients taking stable doses of oral antidepressants for at least 30 days were allowed to continue them
  • Study medication was taken in the evening with fat-containing food
Primary outcome: Change from baseline in the 17-item Hamilton rating scale for depression (HAMD) total score at Day 15 (score ranges from 0 - 52 with higher scores indicating worse depression)
Results

Duration: 45 days
Outcome Zuranolone Placebo Comparisons
Primary outcome (Day 15) -15.6 -11.4 p=0.0007
Primary outcome (Day 3) -9.5 -6.3 p=0.0008
Primary outcome (Day 28) -16.3 -13.5 p=0.0203
Primary outcome (Day 45) -17.7 -14.8 p=0.0067
Somnolence 26.5% 5.1% N/A
Dizziness 13.3% 10.2% N/A
Sedation 11.2% 1% N/A

Findings: Zuranolone was superior to placebo for reducing depressive symptoms in women with PPD




  • Includes sedation and hypersomnia
Side effects reported in a 45-day trial
Side effect Zuranolone 50 mg
(N=98)
Placebo
(N=98)
Somnolence 36% 6%
Dizziness or vertigo 13% 9%
Diarrhea 6% 2%
Fatigue 5% 2%
UTI 5% 4%
Memory impairment 3% 0%
Abdominal pain 3% 0%