Interventions
Each patient received prespecified, open-label ADTs, either an SSRI (sertraline, escitalopram, or citalopram) or an SNRI (duloxetine or desvenlafaxine) from D1 through the end of the study. Patients were stratified by the co-initiated ADT class (SSRI or SNRI) and randomized 1:1 to receive zuranolone 50 mg or matching placebo during the 14-day treatment period. The SOC ADT was assigned at the investigator’s discretion. The dose of ADT could be adjusted based on individual response at the discretion of the investigator.Patients self-administered zuranolone or placebo orally once daily in the evening with fat-containing food for 14 days on an outpatient basis. At the discretion of the investigator, patients who did not tolerate zuranolone 50 mg could receive zuranolone 40 mg for the remainder of the treatment period; patients who did not tolerate zuranolone 40 mg were discontinued from receiving study drug. The dose reduction to 40 mg was prespecified per protocol, with dose reduction by 10 mg showing a positive benefit/risk profile.