Study design
MDD, ≤28
The phase 3, randomized, double-blind, parallel-group, placebo-controlled CORAL Study evaluated the efficacy and safety of zuranolone+ADT in adults with MDD. The study period consisted of a screening period of ≤28 days, followed by a double-blind treatment course of 14 days (treatment period), and then a 28-day follow-up period with continued open-label SOC ADT treatment.The study protocol and all amendments were approved by the appropriate Institutional Review Boards, and the study was performed in accordance with the ethical principles of the Declaration of Helsinki and guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice, as well as all applicable regulatory requirements. All patients provided written informed consent before beginning the study.