| 1 Mean change in YMRS ‐ all participants |
4 |
775 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.59 [‐7.06, ‐4.13] |
| 1.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
238 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.16 [‐7.99, ‐2.32] |
| 1.2 Risperidone v placebo (monotherapy) |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.75 [‐7.46, ‐4.04] |
| 2 YMRS ‐ Baseline |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
0.19 [‐0.82, 1.21] |
| 2.2 Risperidone v placebo (monotherapy) ‐ at baseline |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
0.19 [‐0.82, 1.21] |
| 3 YMRS ‐ at day 3 |
1 |
246 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.8 [‐4.25, ‐1.35] |
| 3.2 Risperidone v placebo (monotherapy) ‐ at day 3 |
1 |
246 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.8 [‐4.25, ‐1.35] |
| 4 YMRS ‐ Week 1 |
3 |
517 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.77 [‐4.26, ‐1.28] |
| 4.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in YMRS |
2 |
230 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.54 [‐5.73, ‐1.36] |
| 4.2 Risperidone v placebo (monotherapy) ‐ at week 1 |
1 |
287 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.10 [‐4.13, ‐0.07] |
| 5 YMRS ‐ Week 2 |
3 |
455 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.53 [‐4.27, ‐0.78] |
| 5.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in YMRS |
2 |
182 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.25 [‐5.06, 0.56] |
| 5.2 Risperidone v placebo (monotherapy) ‐ at week 2 |
1 |
273 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.70 [‐4.93, ‐0.47] |
| 6 YMRS ‐ Week 3 |
3 |
396 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.03 [‐5.87, ‐2.18] |
| 6.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in YMRS |
2 |
142 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.01 [‐6.09, 0.06] |
| 6.2 Risperidone v placebo (monotherapy) ‐ at week 3 |
1 |
254 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.60 [‐6.91, ‐2.29] |
| 7 YMRS ‐ Week 3 endpoint data |
3 |
433 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.30 [‐6.20, ‐2.40] |
| 7.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in YMRS |
2 |
142 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.01 [‐6.09, 0.06] |
| 7.2 Risperidone v placebo (monotherapy) ‐ endpoint data at week 3 |
1 |
291 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.10 [‐7.52, ‐2.68] |
| 8 YMRS ‐ participants without psychotic symptoms at baseline |
3 |
394 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.47 [‐7.35, ‐3.59] |
| 8.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in YMRS |
1 |
58 |
Mean Difference (IV, Fixed, 95% CI) |
‐6.0 [‐10.77, ‐1.23] |
| 8.2 Risperidone v placebo (monotherapy) ‐ change in YMRS |
1 |
139 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.9 [‐9.07, ‐2.73] |
| 8.3 Risperidone v placebo (monotherapy) ‐ YMRS at 3 weeks |
1 |
197 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.00 [‐7.67, ‐2.33] |
| 9 YMRS ‐ participants with psychotic symptoms at baseline |
3 |
241 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.54 [‐8.24, ‐2.84] |
| 9.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in YMRS |
1 |
40 |
Mean Difference (IV, Fixed, 95% CI) |
‐6.1 [‐13.14, 0.94] |
| 9.2 Risperidone v placebo (monotherapy) ‐ change in YMRS |
1 |
107 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.2 [‐8.80, ‐1.60] |
| 9.3 Risperidone v placebo (monotherapy) ‐ YMRS at 3 weeks |
1 |
94 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.90 [‐10.90, ‐0.90] |
| 10 Failure to respond (YMRS) |
4 |
982 |
Risk Ratio (M‐H, Random, 95% CI) |
0.67 [0.51, 0.86] |
| 10.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
151 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.57, 1.04] |
| 10.2 Risperidone v placebo (monotherapy) |
3 |
831 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.45, 0.89] |
| 11 Failure to respond (‐defined as very much or much improved on CGI) |
2 |
254 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.58, 0.91] |
| 11.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
254 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.58, 0.91] |
| 12 Failure to respond (‐defined as very much improved on CGI) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.64, 0.88] |
| 12.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.64, 0.88] |
| 13 Failure to achieve remission (YMRS <= 12) |
2 |
349 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.64, 0.87] |
| 13.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.46, 0.92] |
| 13.2 Risperidone v placebo (monotherapy) |
1 |
246 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.78 [0.66, 0.92] |
| 14 Failure to achieve remission (YMRS <= 8) |
2 |
394 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.69 [0.60, 0.79] |
| 14.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.71 [0.54, 0.94] |
| 14.2 Risperidone v placebo (monotherapy) |
1 |
291 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.68 [0.58, 0.79] |
| 15 Failure to achieve remission (YMRS <= 8 and HAMD‐21 <=7) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.68, 0.97] |
| 15.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.68, 0.97] |
| 16 Failure to achieve sustained remission (YMRS <=8) |
1 |
291 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.57, 0.77] |
| 16.2 Risperidone v placebo (monotherapy) |
1 |
291 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.57, 0.77] |
| 17 Failure to achieve remission (YMRS <= 8 and MADRS <=12) |
1 |
246 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.80, 0.98] |
| 17.1 Risperidone v placebo (monotherapy) |
1 |
246 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.80, 0.98] |
| 18 Mean change in HAMD‐21 |
1 |
63 |
Mean Difference (IV, Fixed, 95% CI) |
1.5 [‐2.11, 5.11] |
| 18.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
63 |
Mean Difference (IV, Fixed, 95% CI) |
1.5 [‐2.11, 5.11] |
| 19 MADRS ‐ baseline |
1 |
291 |
Mean Difference (IV, Fixed, 95% CI) |
0.30 [‐0.47, 1.07] |
| 19.2 Risperidone v placebo (monotherapy) ‐ baseline |
1 |
291 |
Mean Difference (IV, Fixed, 95% CI) |
0.30 [‐0.47, 1.07] |
| 20 MADRS ‐ week 3 |
1 |
254 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.4 [‐2.17, ‐0.63] |
| 20.2 Risperidone v placebo (monotherapy) ‐ week 3 |
1 |
254 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.4 [‐2.17, ‐0.63] |
| 21 MADRS ‐ endpoint data week 3 |
1 |
291 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.40 [‐2.39, ‐0.41] |
| 21.2 Risperidone v placebo (monotherapy) ‐ endpoint data week 3 |
1 |
291 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.40 [‐2.39, ‐0.41] |
| 22 CGI ‐ Baseline |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
0.01 [‐0.13, 0.14] |
| 22.2 Risperidone v placebo (monotherapy) ‐ at baseline |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
0.01 [‐0.13, 0.14] |
| 23 CGI ‐ at week 3 |
1 |
257 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.5 [‐0.76, ‐0.24] |
| 23.2 Risperidone v placebo (monotherapy) ‐ at week 3 |
1 |
257 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.5 [‐0.76, ‐0.24] |
| 24 Change in CGI |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.59 [‐0.79, ‐0.39] |
| 24.2 Risperidone v placebo (monotherapy) |
2 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.59 [‐0.79, ‐0.39] |
| 25 BPRS ‐ baseline |
1 |
289 |
Mean Difference (IV, Fixed, 95% CI) |
1.10 [‐0.65, 2.85] |
| 25.2 Risperidone v placebo (monotherapy) ‐ baseline |
1 |
289 |
Mean Difference (IV, Fixed, 95% CI) |
1.10 [‐0.65, 2.85] |
| 26 BPRS ‐ week 3 |
1 |
253 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.70 [‐3.22, ‐0.18] |
| 26.2 Risperidone v placebo (monotherapy) ‐ week 3 |
1 |
253 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.70 [‐3.22, ‐0.18] |
| 27 BPRS ‐ all participants |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 27.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ change in BPRS |
1 |
138 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.3 [‐8.35, ‐2.25] |
| 27.2 Risperidone v placebo (monotherapy) ‐ BPRS at 3 weeks endpoint data |
1 |
290 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.60 [‐3.44, 0.24] |
| 28 GAS ‐ baseline |
2 |
522 |
Mean Difference (IV, Fixed, 95% CI) |
0.69 [‐1.13, 2.51] |
| 28.2 Risperidone v placebo (monotherapy) ‐ baseline |
2 |
522 |
Mean Difference (IV, Fixed, 95% CI) |
0.69 [‐1.13, 2.51] |
| 29 GAS ‐ week 3 |
1 |
250 |
Mean Difference (IV, Fixed, 95% CI) |
6.90 [3.33, 10.47] |
| 29.2 Risperidone v placebo (monotherapy) ‐ week 3 |
1 |
250 |
Mean Difference (IV, Fixed, 95% CI) |
6.90 [3.33, 10.47] |
| 30 GAS‐ endpoint data week 3 |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 30.1 Risperidone v placebo ‐ change in GAS at endpoint |
1 |
245 |
Mean Difference (IV, Fixed, 95% CI) |
7.0 [3.54, 10.46] |
| 30.2 Risperidone v placebo (monotherapy) ‐ endpoint data week 3 |
1 |
277 |
Mean Difference (IV, Fixed, 95% CI) |
7.30 [3.56, 11.04] |
| 31 Failure to complete treatment |
5 |
1097 |
Risk Ratio (M‐H, Random, 95% CI) |
0.66 [0.52, 0.82] |
| 31.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.51, 0.92] |
| 31.2 Risperidone v placebo (monotherapy) |
3 |
844 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.38, 0.95] |
| 32 Mean duration of treatment |
2 |
549 |
Mean Difference (IV, Fixed, 95% CI) |
2.0 [1.06, 2.94] |
| 32.2 Risperidone v placebo (monotherapy) |
2 |
549 |
Mean Difference (IV, Fixed, 95% CI) |
2.0 [1.06, 2.94] |
| 33 Use of rescue medication (for sedation) |
4 |
806 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.09 [0.98, 1.21] |
| 33.1 Risperidone v placebo (adjunct to mood stabilizer) ‐ lorazepam |
2 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.15 [0.96, 1.37] |
| 33.2 Risperidone v placebo (monotherapy) ‐ lorazepam, diazepam or choral hydrate for 10 days of more |
1 |
294 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.19 [0.86, 1.66] |
| 33.3 Risperidone v placebo (monotherapy) ‐ received lorazepam |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.89, 1.12] |
| 34 Use of antiparkinsonian medication |
2 |
362 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.99 [1.18, 3.35] |
| 34.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.21 [0.73, 6.71] |
| 34.2 Risperidone v placebo (monotherapy) |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.93 [1.07, 3.48] |
| 35 One or more adverse effects |
2 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.88, 1.23] |
| 35.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.88, 1.23] |
| 36 Manic reaction |
4 |
806 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [0.55, 2.61] |
| 36.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.05, 2.06] |
| 36.2 Risperidone v placebo (monotherapy) moderate manic reaction leading to study discontinuation |
1 |
294 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.55 [0.22, 93.93] |
| 36.3 Risperidone v placebo (monotherapy) |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.55 [0.58, 4.15] |
| 37 Weight change (Kg) |
4 |
806 |
Mean Difference (IV, Random, 95% CI) |
1.30 [0.52, 2.07] |
| 37.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Mean Difference (IV, Random, 95% CI) |
1.47 [0.82, 2.13] |
| 37.2 Risperidone v placebo (monotherapy) |
2 |
553 |
Mean Difference (IV, Random, 95% CI) |
1.09 [‐0.42, 2.61] |
| 38 Extrapyramidal ‐related adverse events |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.67 [1.10, 6.44] |
| 38.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.67 [1.10, 6.44] |
| 39 Change in Extrapyramidal Symptom Rating Scale |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.6 [‐0.00, 1.20] |
| 39.2 Risperidone v placebo (monotherapy) |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.6 [‐0.00, 1.20] |
| 40 Extrapyramidal disorder |
4 |
837 |
Risk Ratio (M‐H, Random, 95% CI) |
2.77 [1.32, 5.80] |
| 40.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Random, 95% CI) |
1.88 [0.56, 6.32] |
| 40.2 Risperidone v placebo (monotherapy) |
2 |
584 |
Risk Ratio (M‐H, Random, 95% CI) |
3.30 [1.18, 9.27] |
| 41 Headache |
4 |
802 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.72, 1.55] |
| 41.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.52, 1.68] |
| 41.2 Risperidone v placebo (monotherapy) |
2 |
549 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.15 [0.69, 1.93] |
| 42 Nausea |
2 |
409 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.62 [1.37, 9.54] |
| 42.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.38, 10.59] |
| 42.2 Risperidone v placebo (monotherapy) |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.66 [1.38, 15.73] |
| 43 Dyskinesia |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 8.05] |
| 43.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 8.05] |
| 44 Insomnia |
2 |
440 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.59 [0.30, 1.18] |
| 44.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.5 [0.13, 1.93] |
| 44.2 Risperidone v placebo (monotherapy) |
1 |
290 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.63 [0.28, 1.42] |
| 45 Dyspepsia |
2 |
362 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.35 [0.75, 2.41] |
| 45.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.42, 2.27] |
| 45.2 Risperidone v placebo (monotherapy) |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.75 [0.77, 3.98] |
| 46 Ataxia |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 72.49] |
| 46.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 72.49] |
| 47 Constipation |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.47 [0.26, 8.44] |
| 47.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.47 [0.26, 8.44] |
| 48 Abnormal gait |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.24, 102.42] |
| 48.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.24, 102.42] |
| 49 Dystonia |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 72.49] |
| 49.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 72.49] |
| 50 Somnolence |
5 |
1096 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.17 [2.00, 5.01] |
| 50.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.65 [1.14, 6.13] |
| 50.2 Risperidone v placebo (monotherapy) |
3 |
843 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.39 [1.96, 5.86] |
| 51 Tremor |
4 |
837 |
Risk Ratio (M‐H, Random, 95% CI) |
2.43 [0.68, 8.67] |
| 51.1 Risperidone v placebo (adjunct to mood stabilizer) |
2 |
253 |
Risk Ratio (M‐H, Random, 95% CI) |
1.82 [0.43, 7.67] |
| 51.2 Risperidone v placebo (monotherapy) |
2 |
584 |
Risk Ratio (M‐H, Random, 95% CI) |
3.57 [0.24, 53.51] |
| 52 Tetany |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.24, 102.42] |
| 52.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.24, 102.42] |
| 53 Hyperkinesia |
3 |
703 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.59 [1.86, 6.93] |
| 53.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
11.0 [0.62, 195.48] |
| 53.2 Risperidone v placebo (monotherapy) |
2 |
553 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.23 [1.64, 6.39] |
| 54 Hypertonia |
2 |
444 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.64 [0.90, 14.72] |
| 54.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.5 [0.26, 8.72] |
| 54.2 Risperidone v placebo (monotherapy) |
1 |
294 |
Risk Ratio (M‐H, Fixed, 95% CI) |
11.83 [0.67, 208.03] |
| 55 Dizziness |
2 |
362 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.73 [0.88, 3.38] |
| 55.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.87 [0.88, 53.83] |
| 55.2 Risperidone v placebo (monotherapy) |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.27 [0.61, 2.66] |
| 56 Hypokinesia |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 72.49] |
| 56.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 72.49] |
| 57 Agitation |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.53 [0.34, 125.23] |
| 57.2 Risperidone v placebo (monotherapy) |
1 |
259 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.53 [0.34, 125.23] |
| 58 QTc interval prolongation |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.21, 4.63] |
| 58.1 Risperidone v placebo (adjunct to mood stabilizer) |
1 |
103 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.21, 4.63] |
| 59 Change in parkinsonian subscale |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.5 [‐0.06, 1.06] |
| 59.2 Risperidone v placebo (monotherapy) |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.5 [‐0.06, 1.06] |
| 60 Change in dystonia subscale |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.1 [0.01, 0.19] |
| 60.2 Risperidone v placebo (monotherapy) |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.1 [0.01, 0.19] |
| 61 Change in dyskinesia subscale |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐0.19, 0.19] |
| 61.2 Risperidone v placebo (monotherapy) |
1 |
247 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐0.19, 0.19] |
| 62 Prolactin level at baseline [ng/ml] ‐ (males) |
1 |
147 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.40 [‐4.99, 4.19] |
| 62.2 Risperidone v placebo (monotherapy) |
1 |
147 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.40 [‐4.99, 4.19] |
| 63 Prolactin level at endpoint [ng/ml] ‐ (males) |
1 |
147 |
Mean Difference (IV, Fixed, 95% CI) |
31.0 [25.30, 36.70] |
| 63.2 Risperidone v placebo (monotherapy) |
1 |
147 |
Mean Difference (IV, Fixed, 95% CI) |
31.0 [25.30, 36.70] |
| 64 Prolactin level at baseline [ng/ml] ‐ (females) |
1 |
112 |
Mean Difference (IV, Fixed, 95% CI) |
4.90 [‐2.45, 12.25] |
| 64.2 Risperidone v placebo (monotherapy) |
1 |
112 |
Mean Difference (IV, Fixed, 95% CI) |
4.90 [‐2.45, 12.25] |
| 65 Prolactin level at endpoint [ng/ml] ‐ (females) |
1 |
112 |
Mean Difference (IV, Fixed, 95% CI) |
81.5 [68.43, 94.57] |
| 65.2 Risperidone v placebo (monotherapy) |
1 |
112 |
Mean Difference (IV, Fixed, 95% CI) |
81.5 [68.43, 94.57] |
| 66 Mean change in YMRS ‐ excluding participants on carbamazepine |
1 |
116 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.40 [‐9.84, ‐0.96] |
| 66.2 Risperidone v placebo (monotherapy) |
1 |
116 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.40 [‐9.84, ‐0.96] |
