Measure | Quetiapine XR + Lithium (n= 173) | Quetiapine XR + Placebo (n= 176) |
---|---|---|
Young Mania Rating Scale (YMRS) total score | ||
 LS Mean change (SE) (MMRM) | −22.8 (0.71) | −20.1 (0.71) |
 Mean difference (95% CI) | −2.69 (−4.09, −1.29) | |
 p-value | <0.001 | |
 Mean change (SD) (OC) | −22.6 (7.24) | −20.4 (7.64) |
 n at day 43 | 149 | 147 |
Clinical Global Impressions Bipolar–Severity (CGI-BP-S) | ||
 LS Mean change (SE) (MMRM) | −2.5 (0.08) | −2.2 (0.08) |
 Mean difference (95% CI) | −0.24 (−0.43, −0.04) | |
 p-value | 0.017 | |
 Mean change (SD) (OC) | −2.5 (0.99) | −2.3 (1.00) |
 n at day 43 | 149 | 147 |
Clinical Global Impressions Bipolar-Change (CGI-BP-C) | ||
 LS Mean (SE) (MMRM) | 1.7 (0.09) | 1.9 (0.09) |
 Mean difference (95% CI) | −0.20 (−0.37, −0.03) | |
 p-value | 0.020 | |
 Mean (SD) (OC) | 1.7 (0.69) | 1.9 (0.85) |
 n at day 43 | 149 | 147 |
Positive and Negative Syndrome Scale (PANSS) total score | ||
 LS Mean change (SE) (MMRM) | −19.2 (0.91) | −15.6 (0.91) |
 Mean difference (95% CI) | −3.7 (−5.74, −1.63) | |
 p-value | <0.001 | |
 Mean change (SD) (OC) | −19.8 (12.34) | −16.1 (10.82) |
 n at Day 43 | 148 | 147 |
PANSS positive subscale | ||
 LS Mean change (SE) (MMRM) | −8.1 (0.32) | −7.0 (0.32) |
 Mean difference (95% CI) | −1.1 (−1.85, −0.39) | |
 p-value | 0.003 | |
 Mean change (SD) (OC) | −8.1 (4.47) | −7.1 (4.54) |
 n at day 43 | 148 | 147 |
PANSS activation subscale | Â | Â |
 LS Mean change (SE) (MMRM) | −7.1 (0.28) | −5.9 (0.28) |
 Mean difference (95% CI) | −1.2 (−1.77, −0.61) | |
 p-value | <0.001 | |
 Mean change (SD) (OC) | −7.3 (3.60) | −5.9 (3.77) |
 n at day 43 | 148 | 147 |
Montgomery-Ã…sberg Depression Rating Scale (MADRS) total score | ||
 LS Mean change (SE) (MMRM) | −4.8 (0.37) | −4.1 (0.37) |
 Mean difference (95% CI) | −0.6 (−1.36, 0.07) | |
 p-value | 0.077 | |
 Mean change (SD) (OC) | −5.0 (4.84) | −4.5 (3.56) |
 n at day 43 | 149 | 147 |