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Table 1 Randomised controlled trials (RCTs) assessing the usefulness of aripiprazole in bipolar disorder

From: Efficacy and safety of aripiprazole in the treatment of bipolar disorder: a systematic review

        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CN138-007 unpublished Mania 3 weeks No Yes No 267   134 Agent = placebo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CN138-077/NCT00046384 Unpublished Mania 3 weeks No Yes No 29   27 No results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CN138008 Unpublished Maintenance 14 weeks Haloperidol No No 30 9   No results
CN138-135/NCT00095511 Unpublished Maintenance 40 weeks Lithium No No 56 38   Agent = comparator
  1. Vpx: Valproex