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

Phase 3 Completed 440 enrolled Biogen

RandomizedParallel-groupQuadruple-blindTreatment

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

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

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

Summary

Timeline

Publications

Drugs

Indications