Methods:
MDD
ADVERSE EVENTS, REMISSION
This was a 48-week multicenter randomized double-blind placebo-controlled parallel-group study of patients aged 12–17 years with MDD. Patients received ESC for 12 weeks as an open-label treatment period (open-label period). Patients who achieved criteria for remission or response in the open-label period received either ESC or placebo for 36 weeks as a double-blind treatment period (double-blind period). The primary endpoint was the time to relapse during the double-blind period. Safety was evaluated in terms of type, incidence, and severity of adverse events.