Disposition of patients and baseline characteristics
ideation, Depression
REMISSION
The study drug was administered to 128 patients who completed the screening period and entered the open-label period. Of the 118 patients who reached week 12 of the open-label period, 80 patients met remission or response criteria and were randomized to the double-blind period (39 to ESC and 41 to placebo) (Patient disposition. All 128 patients who transitioned to open-label period were administered investigational drug and became FAS (open-label period). All of the 80 patients who continued in double-blind period and underwent randomization became FAS (double-blind period). FAS (double-blind period) was composed of 39 patients in ESC group and 41 patients in placebo group. ESC, escitalopram; FAS, full analysis set.The patient demographics and baseline characteristics of FAS (open-label period) and FAS (double-blind period) are shown in Patients' Characteristics and Baseline CharacteristicsWho answered “yes” to “(1) Wish to be dead,” “(2) Non-specific active suicidal thoughts,” “(3) Active suicidal ideation with any methods (not plan) without intent to act,” “(4) Active suicidal ideation with some intent to act, without specific plan,” or “(5) Active suicidal ideation with specific plan and intent” in the C-SSRS.Who answered “yes” to “(6) Preparatory acts or behavior,” “(7) Aborted attempt,” “(8) Interrupted attempt,” “(9) Non-fatal suicide attempt,” or “(10) Completed suicide” in the C-SSRS.CDRS-R, Children's Depression Rating Scale-Revised; CGI-S, Clinical Global Impression-Severity Scale; C-SSRS, Columbia-Suicide Severity Rating Scale; CYP, cytochrome P450; EM, extensive metabolizer; PM, poor metabolizer; SD, standard deviation.