ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

Change From Baseline in MADRS Total Score at Day 2

The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.

Time frame: Baseline and Day 2 (24 hours postdose)

Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits

Time frame: Baseline through Day 28

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits

The CGI-S is a clinician-rated assessment of illness severity scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater illness severity.

Time frame: Baseline through Day 28

Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10)

Time frame: Up to Day 28

Proportion of Subjects With Response at Scheduled Postbaseline Visits (≥50% Reduction From Baseline in MADRS Total Score)

Time frame: Up to Day 28

Proportion of Subjects With Sustained Response From Day 2 Through Day 28

Subjects achieving sustained response, defined as a ≥50% reduction from Baseline in MADRS total score, with onset by Day 2 and maintained through the end of the double-blind treatment period.

Time frame: Day 2 through Day 28

Proportion of Subjects With Clinical Global Impression of Improvement (CGI-I) Score of 1 or 2 at Scheduled Postbaseline Visits

The CGI-I is a clinician-rated assessment of change in illness relative to Baseline. Scores range from 1 (very much improved) to 7 (very much worse). This outcome evaluates subjects with a score of 1 (very much improved) or 2 (much improved).

Time frame: Up to Day 28