* The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.
* The secondary efficacy endpoints include:
* Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
* Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score \<29)
* Mean change from Baseline to EOT in CGI-C.
Safety endpoints include:
* Incidence of AEs
* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
* Treatment discontinuation due to AEs
* Suicidality as assessed by the C-SSRS score
* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.
