Efficacy
Depression
REGRESSION, SECONDARY
Results for the open-label period are shown in Secondary Endpoints at the End of Open-Label Period (Full Analysis Set [Open-Label Period])Change in CDRS-R total score, change in CGI-S, CGI-I, and CGI-I improvement rate complemented missing data using LOCF method; CGI-I improvement: 2 or less in CGI-I; Remission: CDRS-R was 28 or less and CGI-S was 2 or less; Response: CDRS-R was 50% or more improvement from start of administration and CGI-S was 2 or less.CDRS-R, Children's Depression Rating Scale-Revised; CGI-I, Clinical Global Impression-Improvement Scale; CGI-S, Clinical Global Impression-Severity Scale; ESC, escitalopram; LOCF, Last Observation Carried Forward; SD, standard deviation.In the double-blind period, there was no statistically significant difference in the primary endpoint of time to relapse between the two groups (Kaplan–Meier plot for time to relapse (FAS [double-blind period]). HR was calculated as hazard ratio of placebo to ESC by Cox regression with treatment group as main effect. CI, confidence interval; FAS, full analysis set; HR, hazard ratio; ESC, escitalopram.The results of the secondary endpoints are shown in Change in CDRS-R total score from start of double-blind period (FAS [double-blind period], LOCF). Change in CDRS-R total score from start double-blind period (week 12) are shown. CDRS-R, Children's Depression Rating Scale-Revised; ESC, escitalopram; FAS, full analysis set; LOCF, Last Observation Carried Forward; SD, standard deviation.Secondary Endpoints at the End of the Double-Blind Period (Full Analysis Set [Double-Blind Period])For change in CDRS-R total score, change in CGI-S, CGI-I, and CGI-I improvement, missing data were imputed using LOCF method; for CGI-S worsening, using WOCF method; CGI-S worsening: worsening 2 or more CGI-S from the start of double-blind period; CGI-I improvement: 2 or less in CGI-I.ESC-placebo.For relapse rate, CGI-S worsening rate and CGI-I improvement rate, Estimates by ANCOVA model (adjusting for each score at the start of double-blind period).CDRS-R, Children's Depression Rating Scale-Revised; CGI-I, Clinical Global Impression-Improvement Scale; CGI-S, Clinical Global Impression-Severity Scale; ESC, escitalopram; LOCF: Last Observation Carried Forward; WOCF: Worst Observation Carried Forward; SD, standard deviation.The change in CGI-S from start of double-blind period to week 48 (LOCF) was −0.1 ± 1.0 in the ESC group and 0.4 ± 1.1 in the placebo group, a statistically significant lower value in the ESC group compared with placebo (CGI-I at week 48 (LOCF) was 1.6 ± 1.0 in the ESC group and 2.1 ± 1.1 in the placebo group, a statistically significant lower value in the ESC group compared with placebo (