Table 1.
List of acute mania trials of aripiprazole and their characteristics
| Trial | Publication | Duration | COMP | PLC | Randomised, N | Efficacy sample, N | Safety sample, N | Results | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AR | COMP | PLC | AR | COMP | PLC | AR | COMP | PLC | ||||||
| CN138-009 | Keck et al., 2003 [27] | 3 weeks | No | Yes | 127 | Agent > PLC | ||||||||
| CN138-074/NCT00036101 | Sachs et al., 2006 [28] | 3 weeks | No | Yes | 137 | 135 | 136 | 132 | 136 | 133 | Agent > PLC | |||
| CN138-135/NCT00095511 | Keck et al., 2009 [29] | 12 weeks | Li | Yes | 155 | 160 | 165 | 154 | 155 | 163 | 154 | 159 | 164 | Agent = comparator > PLC |
| CN138-162/NCT00097266 | Young et al., 2009 [30] | 12 weeks | Hal | Yes | 167 | 165 | 153 | 152 | 161 | 152 | 166 | 165 | 153 | Agent = comparator > PLC |
| CN138-007 | Unpublished | 3 weeks | No | Yes | 267 | 134 | 267 - | 134 - | 267 - | 134 - | Agent = PLC | |||
| CN138-077/NCT00046384 | Unpublished | 3 weeks | No | Yes | 29 | 27 | No results | |||||||
| CN138008 | Vieta et al., 2005 [32] | 12 weeks | Hal | No | 175 | 172 | 171 | 158 | 175 | 169 | Agent > comparator | |||
| All RCTs | ||||||||||||||
| Total by groups | 1,060 | 497 | 746 | 1,005 | 474 | 704 | 1,025 | 493 | 711 | |||||
| Total | 2,303 | 2,183 | 2,229 | |||||||||||
| Only RCTs with PANSS data | ||||||||||||||
| Total by groups | 663 | 497 | 480 | 613 | 474 | 447 | 631 | 493 | 450 | |||||
| Total | 1,640 | 1,534 | 1,574 | |||||||||||
Dash indicates missing data. AR = aripiprazole; COMP = comparator; PANSS = Positive and Negative Syndrome Scale; PLC = placebo; RCT = randomised controlled trial.