A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Summary

The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

Timeline

Start

2020-11-09

Primary completion

2021-10-25

Completion

2021-12-22

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo + Assigned ADT vs SAGE-217 + Assigned ADT; p = 0.0004; LS Mean Difference -1.9 (95% CI -3.0 to -0.9); MMRM NCT04476030 ↗

paper CFB in HAMD-17 total score at Day 3 was significantly improved with zuranolone+ADT vs placebo+ADT PMID 37875578 ↗

release “the CORAL Study in people with major depressive disorder (MDD) met the trial objectives, demonstrating a rapid and statistically significant reduction in depressive symptoms” biogen.com ↗

release “At the Day 3 primary endpoint, zuranolone 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms” biogen.com ↗

Publications

• Parikh SV, Aaronson ST, Mathew SJ, Alva G, DeBattista C, Kanes S, Lasser R, Bullock A, Kotecha M, Jung J, Forrestal F, Jonas J, Vera T, Leclair B, Doherty J. Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study. Neuropsychopharmacology. 2024 Jan;49(2):467-475. doi: 10.1038/s41386-023-01751-9. Epub 2023 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zuranolone	Small molecule	50 mg	Oral
Background	Citalopram	Small molecule	—	Oral
Background	Desvenlafaxine	Other / unclassified	—	Oral
Background	Duloxetine	Small molecule	—	Oral
Background	Escitalopram	Small molecule	—	Oral
Background	Sertraline	Small molecule	—	Oral

Indications