The efficacy of zuranolone versus placebo in postpartum depression and major depressive disorder: a systematic review and meta-analysis

Int J Clin Pharm. 2024 Jun;46(3):590-601. doi: 10.1007/s11096-024-01714-0. Epub 2024 Mar 15.

Abstract

Background: Zuranolone, an oral version of allopregnanolone and neurosteroid, is a novel drug for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Aim: The purpose of this systematic review and meta-analysis was to assess the efficacy of zuranolone in the treatment of MDD and PPD.

Method: A systematic search was conducted using EBSCOhost to simultaneously search Academic Search Premier, APA PsycArticles, APA PsycInfo, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL Ultimate, and MEDLINE with Full Text. Two independent reviewers screened the articles and completed a full-text review using Covidence. The quality of each study was assessed using the Cochrane Risk of Bias tool for randomized trials (RoB 2). A meta-analysis was then conducted using Review Manager (RevMan v5.4) software.

Results: The initial search yielded 127 results, with 6 articles fitting our inclusion and exclusion criteria. All 6 studies, comprising 1707 participants, had an overall low risk of bias. There was a significant decrease in HAM-D scores for MDD at 15 days versus placebo (MD - 2.40, 95% CI - 3.07 to - 1.63; p < .001). When pooling data for PDD, there was an overall significant decrease in HAM-D scores at 15 days versus placebo (MD - 4.06, 95% CI - 4.25 to - 3.87; p < .001).

Conclusion: The results suggest that zuranolone can improve symptoms of PPD at 15 days; however, results were not clinically significant for MDD. Future research is needed to evaluate the long-term efficacy of zuranolone in PPD and the treatment efficacy in MDD.

Keywords: Allopregnanolone; Brexanolone; Depression; Depressive disorder; Major; Neurosteroid; Postpartum; Pregnanolone; Zuranolone.

Publication types

  • Systematic Review
  • Meta-Analysis
  • Review

MeSH terms

  • Antidepressive Agents / therapeutic use
  • Depression, Postpartum* / drug therapy
  • Depressive Disorder, Major* / drug therapy
  • Female
  • Humans
  • Pregnanolone* / therapeutic use
  • Pyrazoles
  • Randomized Controlled Trials as Topic / methods
  • Treatment Outcome

Substances

  • Pregnanolone
  • zuranolone
  • Antidepressive Agents
  • Pyrazoles