PHQ-9 total score
depression, none/mild/moderate depression
The mean change from baseline (SD) to Day 28 in the PHQ-9 total score favored ESK + AD group (-13.0 [6.42]) over AD + PBO group (-10.2 [7.80]; group difference: LS mean [95%CI] = -2.4 [-4.18; -0.69]). The change in PHQ-9 total score from baseline to the endpoint of the double-blind induction phase (LOCF) were consistent with the MMRM analysis (ESK + AD: -12.2 [6.87] vs. AD + PBO: -10.1 [7.87]; group difference: LS mean [95%CI] = -2.2 [-3.93; -0.40]).Improvement in depression severity from baseline to Day 28, favored treatment with ESK + AD over AD + PBO.Examination of severity levels of depression at Day 28 by treatment group showed none/minimal (PHQ-9 total score < 5; ESK + AD: 37 [35.6%] vs AD + PBO: 31 [31.0%]), mild (total score 5–9; ESK + AD: 38 [36.5%] vs. AD + PBO: 29 [29.0%]), moderate (total score 10–14) ESK + AD: 16 [15.4%] vs. AD + PBO: 9 [9.0%]), moderately severe (total score 15–19) ESK + AD: 7 [6.7%] vs. AD + PBO: 13 [13.0%]), and severe (total score ≥ 20; ESK + AD: 6 [5.8%], AD + PBO: 18 [18.0%]). The data showed that the AD + PBO group had a higher proportion of patients with severe depression and the ESK + AD group had a lower proportion of patients with none/mild/moderate depression.