Assessments
Suicidal ideation, TEAEs
SECONDARY
HAMD-17 total score was measured at D1, D3, D8, D12, and D15 (during the double-blind treatment period) and at D18, D21, D28, D35, and D42 of the study (during the ADT continuation period). The effect size for the primary efficacy endpoint was calculated using Cohen’s d. Assessments related to patient-level clinical significance and the other secondary endpoints are described in the Safety and tolerability were assessed by monitoring the incidence and severity of TEAEs as well as by monitoring vital signs, clinical laboratory measurements, and electrocardiograms. Suicidal ideation and behavior were evaluated using the Columbia-Suicide Severity Rating Scale (C-SSRS). Potential withdrawal symptoms following the discontinuation of study drug were monitored using the 20-item Physician Withdrawal Checklist (PWC-20).