Skip to main content

Table 2 Mean changes from baseline to day 43 in primary and secondary efficacy measures (ITT set)

From: Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study

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

  

 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

  1. ITT, intent to treat; LS, least squares; MMRM, mixed-model repeated measures; OC, observed cases. A negative change in score indicates improvement, with the exception of Clinical Global Impressions Bipolar-Change, where a positive change in score indicates improvement. Significant p-values shown in bold.