Safety
overdose, dermatillomania, skin abrasion, ICH, SD, trichotillomania, suicidal behavior, self-injurious ideation, contusion
ADVERSE EVENT, ADVERSE EVENTS, SKIN EROSION, ADVERSE DRUG REACTION, ADVERSE EVENT
The summary of AEs in this study are shown in Summary of Adverse EventsAll adverse events were recorded/classed according to ICH International Glossary of Pharmaceutical Glossary (MedDRA) Ver.25.0.ADR, adverse drug reaction; ESC, escitalopram.In the double-blind period, AE incidence was 82.1% and 56.1% in the ESC and placebo groups, respectively, and ADR incidence was 23.1% and 22.0%, respectively. The severity of most AEs was mild or moderate. In the ESC group, two patients experienced severe AEs, three patients experienced serious AEs, and two patients experienced AEs leading to discontinuation, compared with none in the placebo group. None of these AEs were causally related to ESC.AEs occurring in at least 10% of patients in the open-label period, or in either ESC or placebo groups during the double-blind period are shown in Adverse Events Found in ≥10% (Open-Label and Double-Blind Period)All adverse events were recorded/classed according to ICH International Glossary of Pharmaceutical Glossary (MedDRA) Ver.25.0. Adverse events whose incidence rate was 10% or higher were shown.ESC, escitalopram; PT, preferred term; SOC, system organ class.Suicide-related AEs in this study occurred in 2.3% (3/128) patients as suicide attempt and in 0.8% (1/128) patient as self-injurious ideation and suicidal behavior. Of these, two patients with suicide attempt and one patient with suicidal behavior were judged as ADRs. All of these suicide-related ADRs were observed during the open-label period or follow-up period (post-open-label period) and were serious AEs or AEs leading to discontinuation.In addition, self-injury-related AEs occurred in 10.9% (14/128) patients as skin wound, in 2.3% (3/128) patients as overdose and in 0.8% (1/128) patient as skin abrasion, skin erosion, dermatillomania, trichotillomania, wound, and contusion. Three patients with skin wound, one patient with overdose, one patient with trichotillomania, and one patient with wound were judged as ADRs. All of these ADRs were mild and nonserious, and did not lead to discontinuation, with outcomes of recovered/resolved.For standard 12-lead ECG, the change from baseline in QTc (QTcB and QTcF, same hereinafter; mean ± SD, same hereinafter) were 8.1 ± 17.7 and 6.4 ± 12.1 mseconds in the open-label period, and in the double-blind period were 8.4 ± 19.6 and 7.0 ± 14.4 mseconds in the ESC group, and 2.4 ± 17.3 and 1.4 ± 11.9 mseconds in the placebo group, respectively.Although there was more than one patient with an observed value or change from baseline of QTc above the thresholds (observed value: 450 mseconds, change from baseline: 30 mseconds), the observed value was <480 mseconds and change from baseline was <60 mseconds in all patients. There were no clinically significant changes in laboratory test values, vital signs, or body weight.