Efficacy and safety of zuranolone in the treatment of major depressive disorder: a meta-analysis.

OBJECTIVE

This study aimed to systematically review zuranolone's efficacy and safety in treating major depressive disorder (MDD).

METHODS

We conducted electronic searches in databases like PubMed, Embase, Cochrane, and Web of Science to identify randomized controlled trials using zuranolone for severe depression from study inception to September 15, 2023. Two independent reviewers screened studies, extracted data, and assessed study quality. Our meta-analysis included four studies with 1,454 patients. The findings showed significant improvements with zuranolone across various measures: Hamilton Depression Rating Scale (HAM-D) scores indicated notable alleviation in depressive symptoms (WMD: -2.03; 95% CI: -2.42 to -1.65); the treatment group's HAM-D score response rate was significantly higher than the control group's at day 15 (OR: 1.46, 95% CI: 1.11 to 1.92, = 0.01). The meta-analysis also revealed higher remission rates for the treatment group compared to the control group at day 15 (OR: 1.68, 95% CI: 1.18 to 2.39, = 0.03). Additionally, HAM-A scores on day 15 and MADRS scores on day 15 showed improvement, and HAM-D scores for 30 mg zuranolone on different treatment days exhibited improvement (WMD, -2.55; 95% CI, -3.24 to -1.58; = 0.05). However, analyzing HAM-D scores on day 15 for various zuranolone doses revealed no significant differences. Importantly, zuranolone use was associated with an increased incidence of adverse reactions.

RESULTS

Our meta-analysis included four studies with 1454 patients, showing significant improvements with zuranolone across various measures, including HAM-D scores, HAM-A scores, MADRS scores, and specific HAM-D scores for 30 mg zuranolone on different treatment days. However, no significant differences were found in HAM-D scores on day 15 for various doses of zuranolone.

CONCLUSIONS

Our findings suggest that zuranolone is a promising, simple, and convenient treatment for patients with major depressive disorder, offering potential guidance for clinical practice.