Study design
MDD, Depression, ≤28
ADVERSE EVENTS, REMISSION
This study was a multicenter randomized double-blind placebo-controlled parallel group comparative study conducted at 35 Japanese medical institutions from February 2019 to April 2022.The study consisted of a 1-week screening period, a 12-week open-label treatment period (open-label period), a 36-week double-blind treatment period (double-blind period), and a 3-week follow-up period. Patients who were considered eligible in the screening period entered the open-label period, and ESC was administered orally once daily after dinner for 12 weeks.At week 12, patients who met the criteria of remission (CDRS-R total score of 28 or less and CGI-S of 2 or less) or response (CDRS-R total score of 50% or more improvement and CGI-S of 2 or less) continued in the double-blind period and were randomly assigned to receive ESC or placebo at a 1:1 ratio. ESC or placebo was administered orally once daily after dinner for 36 weeks (Study design. ESC was administered orally to all subjects once daily after dinner for 12 weeks. At week 12, patients who met the criteria of remission (CDRS-R total scores ≤28 and CGI-S ≤2) or response (CDRS-R total scores ≥50% improvement and CGI-S ≤2 from the start of the open-label period) continued in double-blind period and were randomly assigned to receive ESC or placebo at a 1:1 ratio. ESC or placebo was administered orally once daily after dinner for 36 weeks. ESC was administered 10 mg/day for at least 3 weeks, and the dose was allowed to increase to 20 mg/day if the investigator (or sub-investigator) judged lack of efficacy at 3, 5, 7, or 9 weeks and no AEs were found to limit the dose increase. If the investigator (or sub-investigator) judged the patient's tolerability to ESC to be problematic after dose escalation, the study visit was set as needed and the dose could be reduced until week 9. In the double-blind period, the dose at the end of the open-label period was to be administered continuously. AEs, adverse events; CDRS-R, Children's Depression Rating Scale-Revised; CGI-S, Clinical Global Impression-Severity Scale; ESC, escitalopram.The dose of ESC in the open-label period was 10 or 20 mg/day the same dose for MDD patients aged 12–17 years in the United States. ESC 10 mg/day was administered for at least 3 weeks. The dose could be increased to 20 mg/day if the investigators judged lack of efficacy at 3, 5, 7, or 9 weeks and no adverse events (AEs) were found to limit the dose increase. If the investigators judged the patient's tolerability to ESC to be problematic after dose escalation, a study visit was set as needed and the dose could be reduced until week 9. The dose of ESC in the double-blind period was the same dose as at the end of the open-label period.