Table 2.
Aripiprazole for the treatment of bipolar mania, randomized double-blind clinical trials
| Reference | Duration (weeks) | N | Aripiprazole, dose, N | Comparators, dose, N | Comments |
|---|---|---|---|---|---|
| Keck et al 2003 | 3 | 262 | 30 mg (N=130) | Placebo (N=132) | |
| Vieta et al 2005 | 12 | 347 | 15–30 mg (N=175) | Haloperidol 10–15mg (N=172) | Benztropine or other anticholinergics were not permitted |
| Bristol-Myers Squibb 2003b | ? | ? | 15 mg (N=?), 30 mg (N=?) | Placebo (N=?) | Response to aripiprazole did not separate from placebo; data not published, nor posted in the Bristol-Myers Squibb Clinical Trials Disclosure Database |
| Sachs et al 2006 | 3 | 272 | 30 mg (N=137) | Placebo (N=135) | |
| Bristol-Myers Squibb 2003a (CN138-010), and Keck et al 2006 | 26 | 161 | 15–30 mg (N=77) | Placebo (N=83) |