1 Efficacy ‐ response (continuous): change in BPRS from baseline to end of trial |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
1.1 Efficacy ‐ Change in BPRS from baseline to end of trial |
3 |
301 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.82 [‐3.78, 0.14] |
2 Efficacy ‐ response (continuous): MRS (16 item) change from baseline to end of trial |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
2.1 MRS 11 item from SAD‐C |
2 |
271 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.74 [‐5.84, 0.36] |
2.2 MRS Manic Subscale |
2 |
271 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.38 [‐3.02, 0.26] |
2.3 MRS 16 item from SAD‐C |
2 |
271 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.74 [‐7.55, 0.08] |
3 Efficacy ‐ response (continuous): CGI severity change from baseline to end of trial |
3 |
304 |
Mean Difference (IV, Random, 95% CI) |
‐0.35 [‐1.24, 0.53] |
4 Efficacy ‐ response (continuous): change in GAS from baseline to end of trial |
2 |
270 |
Mean Difference (IV, Fixed, 95% CI) |
4.36 [‐0.65, 9.37] |
5 Acceptability |
3 |
|
Odds Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
5.1 All‐cause dropouts |
3 |
303 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.80 [0.50, 1.29] |
5.2 Dropouts due to adverse events |
2 |
273 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.42, 2.06] |
5.3 Dropouts due to lack of efficacy |
2 |
273 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.48, 2.32] |
6 Efficacy ‐ response (continuous): change in Hamilton depression scale (HAMD 31) from baseline to end of trial |
2 |
271 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.74 [‐3.72, 0.24] |
7 Efficacy ‐ response (categorical): ≥ 50% reduction in BPRS from baseline to end of trial |
1 |
30 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.42 [0.09, 1.92] |
8 Efficacy ‐ response(categorical): ≥ 50% reduction in MRS from baseline to end of trial |
1 |
30 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.31 [0.31, 5.58] |
9 Efficacy ‐ response (categorical): CGI scores of 1 or 2 at the end of the trial |
1 |
30 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.42 [0.09, 1.92] |
10 Adverse event: vomiting |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.77 [0.75, 4.18] |
11 Adverse event: all mania |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.63 [0.16, 2.46] |
12 Adverse event: diarrhoea |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.83 [0.92, 15.92] |
13 Adverse event: headache |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.45, 2.02] |
14 Adverse event: tremor |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.28 [0.48, 3.41] |
15 Adverse event: rash |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.58 [0.17, 1.97] |
16 Adverse event: somnolence |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.34, 3.85] |
17 Adverse event: any side effects |
2 |
272 |
Odds Ratio (M‐H, Random, 95% CI) |
0.89 [0.47, 1.70] |
18 Adverse event: any serious event |
1 |
152 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.26, 3.41] |
19 Adverse event: constipation |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.78 [0.18, 3.40] |
20 Adverse event: accidental injury |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.32 [0.43, 4.08] |
21 Adverse event: pain |
2 |
272 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.34 [0.07, 1.65] |
22 Use of concomitant psychotropic medication |
1 |
151 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.07, 0.95] |
23 Mean total dose of lorazepam (g) |
1 |
30 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |