1 Global state: 1. Moderate to severely ill at end of study period (CGI rating) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.92, 1.22] |
2 Global state: 2. Mean change from baseline (CGI‐S, high score = worse) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.1 short term |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐0.04 [‐0.25, 0.17] |
3 Global state: 3. Mean (SD) GAF score change to endpoint |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
3.1 short term |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐0.8 [‐5.66, 4.06] |
4 Global state: 4. Needing use of benzodiazepine or sedative drugs |
2 |
690 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.74, 1.02] |
4.1 short term |
2 |
690 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.74, 1.02] |
5 Mental state: 1. Average change/endpoint scores (PANSS, high score = worse) |
2 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
5.1 mean total (non ITT data) |
1 |
541 |
Mean Difference (IV, Random, 95% CI) |
0.0 [‐2.91, 2.91] |
5.2 average change: 1. total (non ITT data) |
2 |
591 |
Mean Difference (IV, Random, 95% CI) |
1.05 [‐0.77, 2.88] |
5.3 average change: 2. positive (non‐ITT data) |
2 |
591 |
Mean Difference (IV, Random, 95% CI) |
0.83 [‐0.69, 2.35] |
5.4 average change: 3. negative (non ITT data) |
2 |
591 |
Mean Difference (IV, Random, 95% CI) |
0.03 [‐0.76, 0.82] |
5.5 average change: 4. disorganised thoughts |
1 |
541 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.45, 0.65] |
5.6 average change: 5. hostility/excitement |
1 |
541 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.18, 0.38] |
5.7 average change: 6. anxiety/depression |
1 |
541 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.45, 0.65] |
6 Leaving the study early: 1. Any reason |
2 |
690 |
Risk Ratio (M‐H, Random, 95% CI) |
1.28 [0.92, 1.79] |
6.1 short term |
2 |
690 |
Risk Ratio (M‐H, Random, 95% CI) |
1.28 [0.92, 1.79] |
7 Leaving the study early: 2. Specific |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
7.1 adverse events ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.21 [0.62, 2.35] |
7.2 insufficient response ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.51 [0.63, 3.64] |
7.3 withdrawn consent ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.32 [0.65, 2.66] |
8 Quality of life: Mean (SD) SF‐36 score change/endpoint (high score = better) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
8.1 Physical component summary |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
1.4 [‐2.64, 5.44] |
8.2 Mental component summary |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐0.20 [‐5.06, 4.66] |
8.3 Role physical |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
1.0 [‐20.71, 22.71] |
8.4 Role emotional |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐10.60 [‐34.13, 12.93] |
8.5 Vitality |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐1.6 [‐10.24, 7.04] |
8.6 General health |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐2.60 [‐13.14, 7.94] |
8.7 Mental health |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
5.8 [‐5.20, 16.80] |
8.8 Bodily pain |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
3.70 [‐9.89, 17.29] |
8.9 Physical function |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐4.6 [‐14.25, 5.05] |
8.10 Social function |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
18.5 [3.98, 33.02] |
9 Adverse events: 1. General |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 any ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.91, 1.18] |
9.2 death ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.01, 8.20] |
10 Adverse events: 1. General: UKU average change score (high = worse) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
10.1 short term |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐1.99 [‐3.59, ‐0.39] |
11 Adverse events: 2. Specific |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 anxiety |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.40 [0.84, 2.34] |
11.2 psychosis |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.14 [0.58, 2.24] |
11.3 prolactin related |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
0.50 [0.15, 1.65] |
11.4 impotence/ejaculation failure |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.01, 8.20] |
11.5 dysmenorrhoea |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.06, 16.02] |
11.6 hyperprolactinaemia |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
0.20 [0.01, 4.18] |
11.7 galactorrhoea |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.14, 7.10] |
11.8 headache |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.14 [0.66, 1.95] |
11.9 insomnia |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.08 [0.66, 1.74] |
11.10 sexual dysfunction |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
0.50 [0.05, 5.52] |
12 Adverse events: 2. Specific: Mean (SD) weight increase in kg |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
12.1 short term |
1 |
640 |
Mean Difference (IV, Random, 95% CI) |
0.2 [‐0.35, 0.75] |
13 Adverse events: 3. Movement disorder |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 any extra pyramidal symptoms ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.59, 1.88] |
13.2 participants requiring anti‐cholinergic drugs ‐ short term |
2 |
690 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.66, 1.60] |
13.3 tardive dyskinesia ‐ short term |
1 |
640 |
Risk Ratio (M‐H, Random, 95% CI) |
9.06 [0.49, 167.52] |
14 Adverse events: Mean (SD) change in movement disorder rating scales |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
14.1 AIMS |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
1.16 [‐1.23, 3.55] |
14.2 BARS |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
0.16 [‐0.65, 0.97] |
14.3 SAS |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
‐0.55 [‐3.71, 2.61] |