Table 3 Efficacy measures: baseline and end point values in the open-label stabilization phase (ITT population)
Total (N = 162) | Baseline Depressive Symptoms (n = 59) | Baseline Manic or Mixed Symptoms (n = 103) | |
|---|---|---|---|
CGI-BP-S, mean (SD) | |||
Baseline | 4.3 (0.8) | 4.2 (0.8) | 4.3 (0.8) |
Change from baseline | |||
Completersa | -2.1 (1.4)e | -1.9 (1.5)e | -2.2 (1.3)e |
LOCF end pointb | -1.8 (1.5)e | -1.5 (1.6)e | -2.0 (1.5)e |
MADRS, mean (SD) | |||
Baseline | 15.0 (11.6) | 25.4 (6.4) | 9.0 (9.5) |
Change from baseline | |||
Completersa | -7.2 (11.2)e | -15.6 (10.7)e | -2.2 (8.1)d |
LOCF end pointb | -6.0 (12.6)e | -14.0 (11.2)e | -1.4 (11.0) |
YMRS, mean (SD) | |||
Baseline | 18.8 (12.1) | 5.8 (4.5) | 26.3 (8.2) |
Change from baseline | |||
Completersa | -14.2 (12.5)e | -2.3 (5.5)d | -21.2 (9.9)e |
LOCF end pointb | -13.2 (13.8)e | -0.9 (8.6) | -20.2 (11.1)e |
GAF | |||
≥10-point improvement (%)e | |||
Completersa | 68.9 | 63.6 | 72.0 |
LOCF end pointc | 62.3 | 56.4 | 65.9 |
Baseline, mean (SD) | 50.9 (11.4) | 52.5 (10.0) | 49.9 (12.1) |
Change from baseline, mean (SD) | |||
Completersa | 19.0 (16.7)e | 15.5 (16.4)e | 21.0 (16.7)e |
LOCF end pointc | 16.3 (17.1)e | 13.0 (16.6)e | 18.4 (17.1)e |