1 Efficacy ‐ response (continuous): YMRS/MRS change at the end of the study |
3 |
241 |
Mean Difference (IV, Fixed, 95% CI) |
7.28 [5.22, 9.34] |
2 Efficacy ‐ remission (categorical): YMRS < 12/ absence of DSM‐IV mania by end of trial |
2 |
211 |
Odds Ratio (M‐H, Random, 95% CI) |
1.30 [0.11, 14.95] |
3 Efficacy ‐ response (continuous): CGI change from baseline to end of trial |
2 |
62 |
Mean Difference (IV, Fixed, 95% CI) |
0.90 [0.39, 1.41] |
4 Drowsiness/ somnolence |
2 |
219 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.24, 0.75] |
5 Diarrhoea |
2 |
219 |
Odds Ratio (M‐H, Fixed, 95% CI) |
4.14 [1.12, 15.26] |
6 Nausea |
2 |
219 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.49 [1.32, 4.69] |
7 Drowsiness/ somnolence |
1 |
46 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.0 [0.27, 3.73] |
8 Total withdrawal |
3 |
255 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.85 [1.02, 3.34] |
9 Vomiting |
2 |
219 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.80 [1.22, 6.42] |
10 Withdrawal due to adverse effects |
1 |
179 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.80 [0.72, 10.91] |
11 CGI‐BP‐IM response |
1 |
179 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.14, 0.47] |
12 Appetite increase |
1 |
173 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.31 [0.16, 0.59] |
13 Constipation |
1 |
173 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.11, 1.74] |
14 Frequent urination |
2 |
219 |
Odds Ratio (M‐H, Fixed, 95% CI) |
5.29 [2.12, 13.21] |
15 Weight gain |
1 |
173 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.10 [0.03, 0.32] |
16 Dry mouth |
1 |
173 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.42 [1.02, 5.75] |
17 Abdominal Pain |
1 |
173 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.98 [1.91, 8.27] |
18 Concomitant medication: mean total lorazepam (mg) |
1 |
30 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
19 Concomitant medication: use of orphenadrine |
1 |
30 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.17 [0.01, 3.96] |