A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Summary

The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

Timeline

Start

2020-06-08

Primary completion

2022-03-15

Completion

2022-04-12

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs SAGE-217 50 mg; p = 0.0007; Least Square Mean Difference -4.0 (95% CI -6.3 to -1.7); MMRM NCT04442503 ↗

Publications

• Deligiannidis KM, Meltzer-Brody S, Maximos B, Peeper EQ, Freeman M, Lasser R, Bullock A, Kotecha M, Li S, Forrestal F, Rana N, Garcia M, Leclair B, Doherty J. Zuranolone for the Treatment of Postpartum Depression. Am J Psychiatry. 2023 Sep 1;180(9):668-675. doi: 10.1176/appi.ajp.20220785. Epub 2023 Jul 26.

Drugs

Indications