Table 2 Mean change from baseline to Week 6 in efficacy rating scale scores
Improvement in calmness | MADRS Total score | CGI-S score | SDS Mean score | |||
|---|---|---|---|---|---|---|
Yes (n = 83) | No (n = 20) | Yes (n = 83) | No (n = 20) | Yes (n = 83) | No (n = 20) | |
Mean (SD) at baseline | 29.7 (5.3) | 29.5 (6.5) | 4.3 (0.5) | 4.5 (0.5) | 6.4 (1.7) | 6.8 (1.6) |
LS mean (SE) change to Week 6 | − 18.5 (0.8) | − 13.9 (1.8) | − 2.1 (0.1) | − 1.4 (0.2) | − 3.4 (0.3) | − 2.1 (0.6) |
Difference (95% CLs) | − 4.57 (− 0.81, − 8.34) | − 0.64 (− 0.17, − 1.11) | − 1.36 (− 0.11, − 2.62) | |||
p value | 0.018 | 0.0082 | 0.033 | |||
Improvement in life engagement | MADRS Total score | CGI-S score | SDS Mean score | |||
|---|---|---|---|---|---|---|
Yes (n = 92) | No (n = 11) | Yes (n = 92) | No (n = 11) | Yes (n = 92) | No (n = 11) | |
Mean (SD) at baseline | 29.8 (5.4) | 29.0 (7.0) | 4.3 (0.5) | 4.6 (0.5) | 6.5 (1.7) | 6.4 (1.4) |
LS mean (SE) change to Week 6 | − 18.7 (0.8) | − 9.3 (2.1) | − 2.1 (0.1) | − 0.8 (0.3) | − 3.5 (0.3) | − 0.9 (0.7) |
Difference (95% CLs) | − 9.39 (− 4.95, − 13.83) | − 1.36 (− 0.82, − 1.90) | − 2.58 (− 1.09, − 4.07) | |||
p value | < 0.0001 | < 0.0001 | 0.0009 | |||
Improvement in both calmness and life engagement | MADRS Total score | CGI-S score | SDS Mean score | |||
|---|---|---|---|---|---|---|
Yes (n = 80) | No (n = 23) | Yes (n = 80) | No (n = 23) | Yes (n = 80) | No (n = 23) | |
Mean (SD) at baseline | 29.7 (5.0) | 29.0 (5.8) | 4.3 (0.5) | 4.5 (0.5) | 6.4 (1.7) | 6.8 (1.6) |
LS mean (SE) change to Week 6 | − 18.3 (0.8) | − 13.3 (1.6) | − 2.1 (0.1) | − 1.4 (0.2) | − 3.5 (0.3) | − 1.9 (0.5) |
Difference (95% CLs) | − 5.04 (− 1.57, − 8.51) | − 0.75 (− 0.32, − 1.18) | − 1.65 (− 0.49, − 2.81) | |||
p value | 0.0048 | 0.0009 | 0.0057 | |||