| 1 Clinically important response (defined by author) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.1 short term (up to 12 weeks) |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.33 [0.86, 2.07] |
| 1.2 medium term (13 to 26 weeks) |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.6 [0.87, 2.94] |
| 2 Global state: 1. CGI: Average change CGI‐SI (high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 2.1 short term (up to 12 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
0.7 [‐0.01, 1.41] |
| 2.2 medium term (13 to 26 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
0.90 [0.13, 1.67] |
| 3 Mental state: 2a. General ‐ average change score (BPRS total, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 3.1 short term (up to 12 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
7.1 [‐1.15, 15.35] |
| 3.2 medium term (13 to 26 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
9.3 [0.10, 18.50] |
| 4 Mental state: 2b. General ‐ average change score (PANSS total, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 4.1 short term (up to 12 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
12.0 [‐2.03, 26.03] |
| 4.2 medium term (13 to 26 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
16.20 [0.41, 31.99] |
| 5 Mental state: 2c. Positive symptoms ‐ average change score (BPRS positive sub‐score, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 5.1 short term (up to 12 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
2.3 [‐0.67, 5.27] |
| 5.2 medium term (13 to 26 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
2.90 [‐0.29, 6.09] |
| 6 Mental state: 2d. Positive symptoms ‐ average endpoint score (PANSS positive sub‐score, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 6.1 short term (up to 12 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
‐5.1 [‐9.68, ‐0.52] |
| 6.2 medium term (13 to 26 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
‐5.1 [‐9.82, ‐0.38] |
| 7 Mental state: 2e. Negative symptoms ‐ average change score (BPRS negative sub‐score, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 7.1 short term (up to 12 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
1.20 [‐0.47, 2.87] |
| 7.2 medium term (13 to 26 weeks) |
1 |
55 |
Mean Difference (IV, Random, 95% CI) |
1.70 [‐0.31, 3.71] |
| 8 Mental state: 2f. Negative symptoms ‐ average change score (PANSS negative sub‐score, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 8.1 short term (up to 12 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
2.40 [‐0.96, 5.76] |
| 8.2 medium term (13 to 26 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
3.0 [‐1.22, 7.22] |
| 9 Mental state: 2g. General psychopathology ‐ average change score (PANSS general psychopathology sub‐score, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 9.1 short term (up to 12 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
6.20 [‐0.90, 13.30] |
| 9.2 medium term (13 to 26 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
8.2 [0.43, 15.97] |
| 10 Mental state: 2h. Anxiety ‐ average change score (HAMA, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 10.1 short term (up to 12 weeks) |
1 |
54 |
Mean Difference (IV, Random, 95% CI) |
4.00 [0.08, 7.92] |
| 10.2 medium term (13 to 26 weeks) |
1 |
59 |
Mean Difference (IV, Random, 95% CI) |
6.0 [‐0.12, 12.12] |
| 11 Satisfaction with treatment: 1. Average change score (DAI, low = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 11.1 short term (up to 12 weeks) |
1 |
52 |
Mean Difference (IV, Random, 95% CI) |
‐1.2 [‐2.44, 0.04] |
| 11.2 medium term (13 to 26 weeks) |
1 |
52 |
Mean Difference (IV, Random, 95% CI) |
‐1.1 [‐2.08, ‐0.12] |
| 12 Adverse effects: 1. General |
1 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 12.1 at least one adverse effect ‐ medium term (13 to 26 weeks) |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
1.53 [1.02, 2.31] |
| 13 Adverse effects: 2. Anticholinergic effect |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 13.1 concomitant anticholinergic medication ‐ average endpoint dosage (mg/d) ‐ short term (up to 12 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
0.89 [0.35, 1.43] |
| 13.2 concomitant anticholinergic medication ‐ average endpoint dosage (mg/d) ‐ medium term (13 to 26 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
1.08 [0.28, 1.88] |
| 14 Adverse effects: 3a. Central nervous system |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 14.1 insomnia ‐ short term (up to 12 weeks) |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
13.0 [0.76, 220.96] |
| 15 Adverse effects: 3b. CNS (LSEQ, low = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 15.1 awakening from sleep average endpoint score ‐ short term (up to 12 weeks) |
1 |
53 |
Mean Difference (IV, Random, 95% CI) |
‐2.7 [‐10.18, 4.78] |
| 15.2 behaviour following wakefulness average endpoint score ‐ short term (up to 12 weeks) |
1 |
53 |
Mean Difference (IV, Random, 95% CI) |
‐6.60 [‐13.92, 0.72] |
| 15.3 getting to sleep average endpoint score ‐ short term (up to 12 weeks) |
1 |
53 |
Mean Difference (IV, Random, 95% CI) |
‐4.4 [‐14.18, 5.38] |
| 15.4 sleep quality ‐ average endpoint score ‐ short term (up to 12 weeks) |
1 |
53 |
Mean Difference (IV, Random, 95% CI) |
‐6.10 [‐15.97, 3.77] |
| 16 Adverse effects: 4a. Extrapyramidal effects |
1 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 16.1 akathisia ‐ short term (up to 12 weeks) |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
3.0 [0.90, 10.01] |
| 16.2 hypertonia ‐ short term (up to 12 weeks) |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
3.0 [0.33, 27.23] |
| 16.3 tremor ‐ short term (up to 12 weeks) |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
1.0 [0.22, 4.56] |
| 17 Adverse effects: 4b. Extrapyramidal effects ‐ average change score (SAS, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 17.1 short term (up to 12 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
4.20 [1.68, 6.72] |
| 17.2 medium term (13 to 26 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
4.0 [1.02, 6.98] |
| 18 Adverse effects: 4c. Extrapyramidal effects ‐ average change score (HAS, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 18.1 short term (up to 12 weeks) |
1 |
59 |
Mean Difference (IV, Random, 95% CI) |
6.6 [0.88, 12.32] |
| 18.2 medium term (13 to 26 weeks) |
1 |
59 |
Mean Difference (IV, Random, 95% CI) |
6.0 [‐0.12, 12.12] |
| 19 Adverse effects: 4d. Extrapyramidal effects ‐ average change score (AIMS, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 19.1 short term (up to 12 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
1.1 [‐0.11, 2.31] |
| 19.2 medium term (13 to 26 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
1.1 [‐0.45, 2.65] |
| 20 Adverse effects: 5. Other adverse events |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 20.1 weight gain ‐ medium term (13 to 26 weeks) |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.09 [0.01, 1.57] |
| 21 Adverse effects: 5b. Other adverse events |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 21.1 concomitant anxiolytics medication average dosage (mg/d) ‐ short term (up to 12 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
4.65 [0.07, 9.23] |
| 21.2 concomitant anxiolytics medication ‐ average dosage (mg/d)‐ medium term (13 to 26 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
6.10 [0.63, 11.57] |
| 21.3 effects on physiology ‐ supine systolic blood pressure (average in mmHg) ‐ short term (up to 12 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
‐10.0 [‐18.11, ‐1.89] |
| 21.4 effects on physiology ‐ supine systolic blood pressure (average in mmHg) ‐ medium term (13 to 26 weeks) |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
‐10.0 [‐18.11, ‐1.89] |
| 22 Adverse effects: 5c. Other (skewed) |
|
|
Other data |
No numeric data |
| 22.1 weight gain (average weight in kg) ‐ short term (up to 12 weeks) |
|
|
Other data |
No numeric data |
| 22.2 weight gain (average weight in kg) ‐ medium term (13 to 26 weeks) |
|
|
Other data |
No numeric data |
| 23 Leaving the study early |
1 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 23.1 inefficacy ‐ short term (up to 12 weeks) |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
3.0 [0.33, 27.23] |
| 23.2 adverse effects ‐ medium term (13 to 26 weeks) |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
9.00 [0.51, 160.17] |
