Outcomes
Suicide ideation
ADVERSE EVENTS
The primary efficacy endpoint was the change of MADRS total score from baseline to the end of week 8. Secondary efficacy endpoints were the changes from baseline of the following scores at the end of week 8: Hamilton Rating Scale for Depression-17 item (HAM-DSafety assessments included adverse events (AEs), withdrawal due to AEs, vital signs, physical examination, laboratory tests (hematology, serum chemistry, serum prolactin, and urinalysis), and 12-lead ECGs. Suicide ideation and behavior and sexual function were assessed using Colombia-Suicide Severity Rating Scale (C-SSRS) [