Suicidal ideation and behavior
TRD, illness, ideation
ADVERSE EVENTS, EVENT
Overall, 5.6% of participants experienced 1 or more adverse events potentially related to suicidality. Of these, one participant died by suicide. This individual was a 48-year-old male who did not respond to esketamine (MADRS total score was 35 at baseline and 41 and 25 on days 15 and 22, respectively). The participant died by suicide 4 days after the most recent esketamine dose. Considering this individual’s long history of mental illness and underlying TRD, the event was reported by the site investigator as not related to esketamine.In the C-SSRS assessment, 49 participants (of 1144; 4.3%) with no history of suicidal ideation reported new occurrences of suicidal ideation during the study. Ten (0.9%) participants reported new suicidal behavior, 9 of whom had a previous history of suicidal ideation. Improvement in severity category of C-SSRS assessment from baseline to postbaseline occurred in 14.0% of participants (