Table 1.
Patients (n) | ||||||||||
Trial no. | Publication | Target | Duration | Comparator | Placebo | Add on | Agent | Comparator | Placebo | Comments |
CN138-009 | Keck et al., 2003 [68] | Mania | 3 weeks | No | Yes | No | 130 | 132 | Agent > placebo | |
CN138-074/NCT00036101 | Sachs et al., 2006 [69] | Mania | 3 weeks | No | Yes | No | 137 | 135 | Agent > placebo | |
CN138-135/NCT00095511 | Keck et al., 2009 [70] | Mania | 12 weeks | Lithium | Yes | No | 155 | 160 | 165 | Agent = comparator > placebo |
CN138-162/NCT00097266 | Young et al., 2009 [71] | Mania | 12 weeks | Haloperidol | Yes | No | 167 | 165 | 153 | Agent = comparator > placebo |
CN138-007 | unpublished | Mania | 3 weeks | No | Yes | No | 267 | 134 | Agent = placebo | |
CN138-013 | Zimbroff et al., 2007 [74] | Mania | 24 h | Lorazepam | Yes | No | 156 | 70 | 75 | Agent = comparator > placebo |
CN138-077/NCT00046384 | Unpublished | Mania | 3 weeks | No | Yes | No | 29 | 27 | No results | |
CN138008 | Vieta et al., 2005 [72] | Mania | 12 weeks | Haloperidol | No | No | 175 | 172 | Agent > comparator | |
CN138-134/NCT00257972 | Vieta et al., 2008 [73] | Mania | 6 weeks | No | Yes | Lithium/Vpx | 253 | 131 | Agent > placebo | |
CN138-096/NCT00080314 | Thase et al., 2008 [75] | Bipolar depression | 8 weeks | No | Yes | No | 186 | 188 | Agent = placebo | |
CN138-146/NCT00094432 | Thase et al., 2008 [75] | Bipolar depression | 8 weeks | No | Yes | No | 187 | 188 | Agent = placebo | |
CN138-010/NCT00036348 | Keck et al., 2006/7 [76,77]; Muzina et al., 2008 [78] | Maintenance | 26 to 100 weeks | No | Yes | No | 77 | 83 | Agent > placebo | |
CN138008 | Unpublished | Maintenance | 14 weeks | Haloperidol | No | No | 30 | 9 | No results | |
CN138-135/NCT00095511 | Unpublished | Maintenance | 40 weeks | Lithium | No | No | 56 | 38 | Agent = comparator |
Vpx: Valproex