| 1 Mental state: 1a. General ‐ average endpoint score ‐ immediate (BPRS/PANSS total, higher score = poor) |
6 |
171 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.01 [‐0.29, 0.32] |
| 1.1 DHEA |
3 |
106 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.02 [‐0.40, 0.37] |
| 1.2 ketoconazole |
1 |
15 |
Std. Mean Difference (IV, Fixed, 95% CI) |
1.15 [0.03, 2.28] |
| 1.3 mifepristone |
2 |
50 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.21 [‐0.77, 0.36] |
| 2 Mental state: 1b. General ‐ average endpoint score ‐ immediate (BPRS/PANSS total, high score = poor, skewed data) |
|
|
Other data |
No numeric data |
| 3 Mental state: 1c. General ‐ average endpoint score ‐ short term ‐ only mifepristone (BPRS total, higher score = poor) |
1 |
20 |
Mean Difference (IV, Fixed, 95% CI) |
2.10 [‐2.86, 7.06] |
| 4 Mental state: 2a. Specific ‐ positive symptoms ‐ average endpoint scores ‐ immediate (BPRS/PANSS positive subscale, higher score = poor) |
5 |
151 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.07 [‐0.40, 0.25] |
| 4.1 DHEA |
3 |
106 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.06 [‐0.32, 0.44] |
| 4.2 ketoconazole |
1 |
15 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.03 [‐1.05, 0.98] |
| 4.3 mifepristone |
1 |
30 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.59 [‐1.32, 0.14] |
| 5 Mental state: 2b. Specific ‐ negative symptoms ‐ average endpoint scores ‐ immediate (PANSS negative subscale, higher score = poor) |
3 |
94 |
Mean Difference (IV, Fixed, 95% CI) |
2.21 [‐0.14, 4.55] |
| 5.1 DHEA |
2 |
79 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.34 [‐3.29, 2.62] |
| 5.2 ketoconazole |
1 |
15 |
Mean Difference (IV, Fixed, 95% CI) |
6.49 [2.65, 10.33] |
| 6 Mental state: 2c. Specific ‐ negative symptoms ‐ average endpoint scores ‐ immediate ‐ only DHEA (SANS, high score = poor, skewed data) |
|
|
Other data |
No numeric data |
| 7 Mental state: 2d. Specific ‐ anxiety symptoms ‐ average endpoint scores ‐ only DHEA (HAMA total, higher score = poor, skewed data) |
|
|
Other data |
No numeric data |
| 8 Mental state: 2e. Specific ‐ depression ‐ average endpoint scores ‐ only mifepristone (HAMD total, higher score = poor) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 8.1 immediate |
1 |
30 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.20 [‐9.12, 2.72] |
| 8.2 short‐term |
1 |
20 |
Mean Difference (IV, Fixed, 95% CI) |
0.90 [‐3.75, 5.55] |
| 9 Mental state: 2f. Specific ‐ depression ‐ average endpoint scores (CDSS/HAMD total, high score = poor, skewed data) |
|
|
Other data |
No numeric data |
| 9.1 DHEA |
|
|
Other data |
No numeric data |
| 9.2 ketoconazole |
|
|
Other data |
No numeric data |
| 9.3 mifepristone |
|
|
Other data |
No numeric data |
| 10 Global state: 1. General ‐ no clinically significant improvement ‐ data only for mifepristone (< 30% improvement BPRS) |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.58 [0.32, 1.06] |
| 11 Global state: 2a. Specific ‐ positive symptoms ‐ no clinically significant improvement ‐ data only for mifepristone (< 50% improvement BPRS, PSS) |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.38 [0.18, 0.81] |
| 12 Global state: 2b. Specific ‐ depression ‐ no clinically significant improvement ‐ data only for mifepristone (< 50% improvement HAMD) |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.59, 1.22] |
| 13 Global state: 3. Leaving the study early |
7 |
201 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.56 [0.20, 1.52] |
| 13.1 dexamethasone |
1 |
19 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 13.2 DHEA |
3 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.41 [0.13, 1.28] |
| 13.3 ketoconazole |
1 |
15 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 13.4 mifepristone |
2 |
50 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.13, 68.26] |
| 14 Cognitive functioning: 1a. Average endpoint scores, various tasks |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 14.1 Information processing and sustained attention (serial addition task) |
1 |
19 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.5 [‐1.87, 0.87] |
| 14.2 Spatial thinking (Benton Line Orientation task) |
1 |
19 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐1.63, 1.43] |
| 15 Cognitive functioning: 1b. Vigilance task ‐ average endpoint scores ‐ skewed data |
|
|
Other data |
No numeric data |
| 15.2 Vigilance |
|
|
Other data |
No numeric data |
| 16 General functioning: average endpoint scores GAF/SOFAS (low = poor) |
2 |
54 |
Mean Difference (IV, Fixed, 95% CI) |
1.05 [‐5.55, 7.66] |
| 16.1 DHEA |
2 |
54 |
Mean Difference (IV, Fixed, 95% CI) |
1.05 [‐5.55, 7.66] |
| 17 Adverse effects: 1. General ‐ overall number of events |
8 |
223 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.66 [1.33, 5.32] |
| 17.1 dexamethasone |
1 |
19 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 17.2 DHEA |
4 |
139 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.38, 10.44] |
| 17.3 ketoconazole |
1 |
15 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.19 [0.60, 7.93] |
| 17.4 mifepristone |
2 |
50 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.25 [1.27, 8.33] |
| 18 Adverse effects: 2a. Specific ‐ extrapyramidal symptoms ‐ average endpoint scores ‐ data only for DHEA (SHRS total, higher score = poor) |
1 |
30 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.90 [‐1.66, ‐0.15] |
| 19 Adverse effects: 2b. Specific ‐ extrapyramidal symptoms ‐ average endpoint scores ‐ data only for DHEA (skewed data) |
|
|
Other data |
No numeric data |
| 19.1 extrapyramidal symptoms (ESRS total, higher score = poor) |
|
|
Other data |
No numeric data |
| 19.2 Akathisia and tardive dyskinesia (AIMS/BARS total, higher score = poor) |
|
|
Other data |
No numeric data |
| 20 Adverse effects: 2c. Specific: various effects |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 20.1 allergy ‐ skin rash ‐ data only for mifepristone |
2 |
50 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.67 [0.64, 20.94] |
| 20.2 anticholinergic ‐ minor blurred vision ‐ data only for DHEA |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.13, 68.26] |
| 20.3 cardiovascular ‐ mild dizziness ‐ data only for ketoconazole |
1 |
15 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.19 [0.60, 7.93] |
| 20.4 gastrointestinal ‐ appetite ‐ increase ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.58] |
| 20.5 central nervous system ‐ fatigue ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.20, 19.78] |
| 20.6 central nervous system ‐ irritability/agitation ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.26, 96.13] |
| 20.7 gastrointestinal ‐ appetite ‐ decrease ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.13, 68.26] |
| 20.8 gastrointestinal ‐ constipation ‐ data only for DHEA |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.26, 96.13] |
| 20.9 gastrointestinal ‐ constipation ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.26, 96.13] |
| 20.10 gastrointestinal ‐ nausea ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.58] |
| 20.11 hormonal ‐ dysmenorrhoea ‐ data only for mifepristone |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.13, 68.26] |
| 21 Quality of life: observer‐rated scale |
1 |
55 |
Mean Difference (IV, Fixed, 95% CI) |
6.20 [‐1.37, 13.77] |
| 21.1 DHEA |
1 |
55 |
Mean Difference (IV, Fixed, 95% CI) |
6.20 [‐1.37, 13.77] |
