1 Efficacy ‐ response (continuous): YMRS change by ≥ 50% at end of trial |
1 |
309 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.62, 1.51] |
2 Efficacy ‐ response (continuous): CGI BP change from baseline to end of trial |
1 |
309 |
Mean Difference (IV, Random, 95% CI) |
0.20 [0.18, 0.22] |
3 Efficacy ‐ remission (categorical): YMRS < 12 at end of trial |
1 |
309 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.99 [0.63, 1.56] |
4 PANSS change from baseline to end of trial |
1 |
268 |
Mean Difference (IV, Random, 95% CI) |
2.5 [2.16, 2.84] |
5 Total withdrawal |
1 |
315 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.60, 1.46] |
6 CGI‐BP severity of illness score change from baseline to end of trial |
1 |
307 |
Mean Difference (IV, Random, 95% CI) |
0.30 [0.28, 0.32] |
7 MADRS change from baseline to end of trial |
1 |
309 |
Mean Difference (IV, Random, 95% CI) |
1.0 [0.87, 1.13] |
8 CGI BP depression change from baseline to end of trial |
1 |
307 |
Mean Difference (IV, Random, 95% CI) |
0.10 [0.08, 0.12] |
9 Weight |
1 |
313 |
Mean Difference (IV, Random, 95% CI) |
‐0.78 [‐0.89, ‐0.67] |
10 Akathisia |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.18, 1.02] |
11 Constipation |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.50, 2.13] |
12 Headache |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.83 [0.48, 1.41] |
13 Nausea |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.61, 1.75] |
14 Somnolence/ sedation |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.56 [0.26, 1.23] |
15 Tremor |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.45 [0.65, 3.24] |
16 EPSE |
1 |
313 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.60 [0.34, 1.07] |
17 Clinically relevant (> 7%) weight gain |
1 |
184 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.07 [0.18, 23.21] |
18 Simpson Angus scale EPS LOCF |
1 |
313 |
Mean Difference (IV, Random, 95% CI) |
‐0.51 [‐0.54, ‐0.48] |
19 BARS score |
1 |
313 |
Mean Difference (IV, Random, 95% CI) |
‐0.17 [‐0.18, ‐0.16] |
20 Withdrawal due to lack of efficacy |
1 |
315 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.15 [1.42, 6.96] |
21 Withdrawal due to adverse events |
1 |
315 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.43, 1.56] |
22 Concomitant use of anxiolytics |
1 |
315 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.72 [0.34, 1.53] |
23 Concomitant use of analgesics/antipyretics |
1 |
315 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.05 [0.66, 1.67] |
24 Concomitant use of anticholinergics |
1 |
315 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.34 [0.17, 0.69] |