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Grand Rounds

RCT Results: Does Zuranolone Improve Postpartum Depression Symptoms?

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BACKGROUND AND PURPOSE:

  • Evidence suggests that GABAergic signaling plays a role in the development of postpartum depression (PPD)
  • Zuranolone is a neuroactive steroid (NAS) GABAA receptor (GABAAR)–positive allosteric modulator (PAM) with a similar method of action to other NAS GABAAR PAMs, but can be taken orally
  • Deligiannidis et al. (JAMA Psychiatry, 2021) assessed the efficacy and safety of zuranolone in PPD

METHODS:

  • Phase 3, double-blind, randomized, outpatient, placebo-controlled clinical trial
  • Participants
    • ≤6 months postpartum | 18 to 45 years
    • With PPD: Major depressive episode beginning third trimester or ≤4 weeks postdelivery
    • Baseline score of ≥26 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
  • Interventions
    • Zuranolone: 30 mg orally every evening for 2 weeks
    • Placebo
  • Study design
    • 1:1 randomization
    • Analysis was by intention to treat
  • Primary outcome
    • Change from baseline in HAMD-17 score at day 15
  • Secondary outcomes
    • Changes from baseline in HAMD-17 score at other time points
    • HAMD-17 response (≥50% score reduction)
    • Remission rates (score ≤7)
    • Montgomery-Åsberg Depression Rating Scale score
    • Hamilton Rating Scale for Anxiety score

RESULTS:

  • Zuranolone: 76 patients | Placebo: 77 patients
    • Mean (SD) age 28.3 (5.4) years
    • 98.7% completed treatment
  • Patients who received zuranolone had significant day 15 HAMD-17 score improvements from baseline, compared to placebo
    • Zuranolone: −17.8
    • Placebo: −13.6
    • Difference −4.2 (95% CI, −6.9 to −1.5); P=0.003
  • Sustained differences in HAMD-17 scores favoring zuranolone were observed from day 3 through day 45
    • Day 3: Difference −2.7 (95% CI, −5.1 to −0.3); P=0.03
    • Day 45: Difference −4.1 (95% CI, −6.7 to −1.4); P=0.003
  • Sustained differences at day 15 favoring zuranolone were observed in
    • HAMD-17 response
      • Odds ratio (OR) 2.63 (95% CI, 1.34 to 5.16); P=0.005
    • HAMD-17 score remission
      • OR 2.53 (95% CI, 1.24 to 5.17); P = 0.01
    • Change from baseline for Montgomery-Åsberg Depression Rating Scale score
      • Difference −4.6 (95% CI, −8.3 to −0.8); P=0.02
    • Hamilton Rating Scale for Anxiety score
      • Difference −3.9 (95% CI, −6.7 to −1.1); P=0.006
  • One patient per group experienced a serious adverse event
    • Zuranolone group: confusional state
    • Placebo: pancreatitis

CONCLUSION:

  • Compared to placebo, zuranolone significantly improved depressive symptoms in women with PPD
  • Adverse events were minimal
  • The authors state

Zuranolone has the potential to become a novel treatment for patients with PPD

Moreover, the findings of this study, along with prior PPD studies, support the potential for the development and therapeutic use of NAS GABAAR PAMs in the treatment of PPD

Learn More – Primary Sources:

Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial

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FDA Approves First Medication for Treatment of Postpartum Depression
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The Four Maternal Characteristics that Predict Postpartum Depression Severity
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