| 1 Global state: 1a. No clinically significant response (as defined by the original studies) |
3 |
339 |
Risk Ratio (M-H, Random, 95% CI) |
1.11 [0.86, 1.43] |
| 2 Global state: 1b. No clinically important change (as defined by the original studies) |
2 |
309 |
Risk Ratio (M-H, Random, 95% CI) |
1.18 [0.89, 1.57] |
| 2.1 short term |
1 |
42 |
Risk Ratio (M-H, Random, 95% CI) |
1.36 [0.59, 3.15] |
| 2.2 long term |
1 |
267 |
Risk Ratio (M-H, Random, 95% CI) |
1.16 [0.86, 1.57] |
| 3 Leaving the study early |
11 |
|
Risk Ratio (M-H, Random, 95% CI) |
Subtotals only |
| 3.1 any reason |
10 |
1651 |
Risk Ratio (M-H, Random, 95% CI) |
1.22 [1.13, 1.32] |
| 3.2 due to adverse events |
8 |
1573 |
Risk Ratio (M-H, Random, 95% CI) |
0.90 [0.69, 1.18] |
| 3.3 due to inefficacy |
8 |
1563 |
Risk Ratio (M-H, Random, 95% CI) |
1.80 [1.42, 2.27] |
| 4 Mental state: 1a. General - no clinically important change-short term (less than 50% PANSS total score reduction) |
1 |
42 |
Risk Ratio (M-H, Random, 95% CI) |
0.91 [0.54, 1.53] |
| 5 Mental state: 1b. General -average endpoint score (PANSS total, high=poor) |
10 |
1449 |
Mean Difference (IV, Random, 95% CI) |
3.66 [1.93, 5.39] |
| 5.1 short term |
4 |
142 |
Mean Difference (IV, Random, 95% CI) |
2.17 [−1.51, 5.85] |
| 5.2 medium term |
3 |
482 |
Mean Difference (IV, Random, 95% CI) |
5.57 [1.97, 9.17] |
| 5.3 long term |
3 |
825 |
Mean Difference (IV, Random, 95% CI) |
3.40 [0.91, 5.88] |
| 6 Mental state: 2a. Positive symptoms - no clinically important change-short term (less than 20% SAPS total score reduction) |
1 |
30 |
Risk Ratio (M-H, Random, 95% CI) |
15.0 [0.93, 241.20] |
| 7 Mental state: 2b. Positive symptoms - average endpoint score (PANSS positive subscore, high=poor) |
7 |
679 |
Mean Difference (IV, Random, 95% CI) |
1.80 [1.02, 2.59] |
| 7.1 short term |
3 |
115 |
Mean Difference (IV, Random, 95% CI) |
1.05 [−0.75, 2.85] |
| 7.2 medium term |
3 |
483 |
Mean Difference (IV, Random, 95% CI) |
2.21 [0.90, 3.52] |
| 7.3 long term |
1 |
81 |
Mean Difference (IV, Random, 95% CI) |
1.80 [0.39, 3.21] |
| 8 Mental state: 2c. Positive symptoms - SAPS total score - percent change-short term (high=poor) |
1 |
30 |
Mean Difference (IV, Random, 95% CI) |
40.84 [23.97, 57.71] |
| 9 Mental state: 3a. Negative symptoms - no clinically important change-short term (less than 20% SANS total score reduction) |
1 |
30 |
Risk Ratio (M-H, Random, 95% CI) |
1.5 [0.53, 4.26] |
| 10 Mental state: 3b. Negative symptoms - average endpoint score (PANSS negative subscore, high=poor) |
7 |
679 |
Mean Difference (IV, Random, 95% CI) |
0.41 [−0.36, 1.18] |
| 10.1 short term |
3 |
115 |
Mean Difference (IV, Random, 95% CI) |
0.01 [−1.72, 1.73] |
| 10.2 medium term |
3 |
483 |
Mean Difference (IV, Random, 95% CI) |
0.40 [−0.67, 1.47] |
| 10.3 long term |
1 |
81 |
Mean Difference (IV, Random, 95% CI) |
0.70 [−0.73, 2.13] |
| 11 Mental state: 3c. Negative symptoms - average endpoint score-medium term (SANS total score, high=poor) |
1 |
335 |
Mean Difference (IV, Random, 95% CI) |
3.70 [−0.48, 7.88] |
| 12 Mental state: 3d. Negative symptoms - average endpoint score-short term (SANS total score- percent change, high= poor) |
1 |
30 |
Mean Difference (IV, Random, 95% CI) |
2.46 [−31.90, 36.82] |
| 13 General functioning: General - average endpoint score-medium term (GAF total score, high=poor) |
1 |
278 |
Mean Difference (IV, Random, 95% CI) |
3.80 [0.77, 6.83] |
| 14 Quality of life: General -average endpoint score-medium term (QLS total score, high=poor) |
1 |
286 |
Mean Difference (IV, Random, 95% CI) |
1.80 [−2.42, 6.02] |
| 15 Service use: number of participants re-hospitalised |
2 |
876 |
Risk Ratio (M-H, Random, 95% CI) |
1.79 [1.30, 2.47] |
| 15.1 medium term |
1 |
203 |
Risk Ratio (M-H, Random, 95% CI) |
1.8 [0.92, 3.51] |
| 15.2 long term |
1 |
673 |
Risk Ratio (M-H, Random, 95% CI) |
1.78 [1.24, 2.58] |
| 16 Adverse effects: 1. General - at least one adverse effect |
6 |
1269 |
Risk Ratio (M-H, Random, 95% CI) |
0.97 [0.88, 1.06] |
| 17 Adverse effects: 2. Death |
3 |
1410 |
Risk Ratio (M-H, Random, 95% CI) |
0.74 [0.13, 4.23] |
| 17.1 suicide attempt |
2 |
940 |
Risk Ratio (M-H, Random, 95% CI) |
0.35 [0.05, 2.29] |
| 17.2 suicide |
2 |
470 |
Risk Ratio (M-H, Random, 95% CI) |
4.96 [0.24, 102.41] |
| 18 Adverse effects: 3a. Cardiac effects - QTc prolongation |
1 |
673 |
Risk Ratio (M-H, Random, 95% CI) |
12.96 [0.73, 229.17] |
| 19 Adverse effects: 3b. Cardiac effects - QTc abnormalities -change from baseline in ms |
3 |
643 |
Mean Difference (IV, Random, 95% CI) |
4.81 [0.34, 9.28] |
| 20 Adverse effects: 4a. Central nervous system - sedation |
7 |
1615 |
Odds Ratio (M-H, Fixed, 95% CI) |
0.97 [0.78, 1.20] |
| 21 Adverse effects: 4b. Central nervous system - seizures |
1 |
40 |
Risk Ratio (M-H, Random, 95% CI) |
3.3 [0.14, 76.46] |
| 22 Adverse effects: 5a. Extrapyramidal effects |
8 |
|
Risk Ratio (M-H, Random, 95% CI) |
Subtotals only |
| 22.1 akathisia |
6 |
1277 |
Risk Ratio (M-H, Random, 95% CI) |
0.98 [0.68, 1.40] |
| 22.2 akinesia |
1 |
267 |
Risk Ratio (M-H, Random, 95% CI) |
1.02 [0.67, 1.56] |
| 22.3 dystonia |
1 |
42 |
Risk Ratio (M-H, Random, 95% CI) |
4.57 [0.23, 89.72] |
| 22.4 extrapyramidal symptoms |
2 |
245 |
Risk Ratio (M-H, Random, 95% CI) |
1.62 [0.72, 3.67] |
| 22.5 parkinsonism |
1 |
40 |
Risk Ratio (M-H, Random, 95% CI) |
0.66 [0.18, 2.41] |
| 22.6 tremor |
1 |
42 |
Risk Ratio (M-H, Random, 95% CI) |
0.39 [0.12, 1.31] |
| 22.7 use of antiparkinson medication |
6 |
1090 |
Risk Ratio (M-H, Random, 95% CI) |
0.49 [0.30, 0.79] |
| 23 Adverse effects: 5b. Extrapyramidal effects - scale measured |
2 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 23.1 akathisia: Barnes Akathisia Scale (high=poor) |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
−0.10 [−0.58, 0.38] |
| 23.2 extrapyramidal symptoms: ESRS total score (high=poor) |
1 |
33 |
Mean Difference (IV, Random, 95% CI) |
Not estimable |
| 23.3 extrapyramidal symptoms: Simpson-Angus Scale (high=poor) |
1 |
50 |
Mean Difference (IV, Random, 95% CI) |
0.6 [−1.38, 2.58] |
| 24 Adverse effects: 6a. Prolactin associated side effects |
5 |
|
Risk Ratio (M-H, Random, 95% CI) |
Subtotals only |
| 24.1 abnormally high prolactin value |
1 |
42 |
Risk Ratio (M-H, Random, 95% CI) |
0.10 [0.01, 1.77] |
| 24.2 amenorrhea |
3 |
252 |
Risk Ratio (M-H, Random, 95% CI) |
0.66 [0.36, 1.21] |
| 24.3 galactorrhea |
4 |
1025 |
Risk Ratio (M-H, Random, 95% CI) |
0.66 [0.25, 1.73] |
| 24.4 gynecomastia |
1 |
267 |
Risk Ratio (M-H, Random, 95% CI) |
0.33 [0.09, 1.20] |
| 24.5 sexual dysfunction |
4 |
1177 |
Risk Ratio (M-H, Random, 95% CI) |
0.80 [0.64, 0.99] |
| 25 Adverse effects: 6b. Prolactin -change from baseline in ng/ml |
5 |
1021 |
Mean Difference (IV, Random, 95% CI) |
−5.89 [−11.62, −0.16] |
| 26 Adverse effects: 7a. Metabolic - cholesterol - significant cholesterol increase |
1 |
267 |
Risk Ratio (M-H, Random, 95% CI) |
0.99 [0.59, 1.68] |
| 27 Adverse effects: 7b. Metabolic - cholesterol - change from baseline in mg/dl |
4 |
986 |
Mean Difference (IV, Random, 95% CI) |
−4.69 [−13.84, 4.45] |
| 28 Adverse effects: 7c. Metabolic - glucose - abnormally high fasting glucose value |
1 |
267 |
Risk Ratio (M-H, Random, 95% CI) |
0.71 [0.33, 1.54] |
| 29 Adverse effects: 7d. Metabolic -glucose - change from baseline in mg/dl |
4 |
986 |
Mean Difference (IV, Random, 95% CI) |
−9.32 [−17.82, −0.82] |
| 30 Adverse effects: 7e. Metabolic -weight - gain |
8 |
1667 |
Risk Ratio (M-H, Random, 95% CI) |
0.68 [0.51, 0.92] |
| 30.1 significant weight gain (as defined by the original studies) |
7 |
1321 |
Risk Ratio (M-H, Random, 95% CI) |
0.69 [0.51, 0.95] |
| 30.2 as “weight gain” reported adverse events |
1 |
346 |
Risk Ratio (M-H, Random, 95% CI) |
0.49 [0.04, 5.34] |
| 31 Adverse effects: 7f. Metabolic -weight - change from baseline in kg |
7 |
1173 |
Mean Difference (IV, Random, 95% CI) |
−2.68 [−4.26, −1.10] |
