Table 1 Studies used in factor analysis
Study | Duration (weeks) | Efficacy assessments (time points) | Study design | Entry criteria | Treatments | |||
|---|---|---|---|---|---|---|---|---|
YMRS total score | MADRS total score | |||||||
CN138-007 (Sachs et al. 2006a) | 3 | Baseline Days 2, 4, 7, 10, 14, 21 | International, multicenter, double-blind, placebo-controlled study in subjects with bipolar I disorder experiencing acute manic or mixed episodes | ≥20 at randomization | – | Aripiprazole (flexibly dosed 15 to 30 mg/day) | Placebo |  |
CN138-009 (Keck et al. 2003) | 3 | Baseline Days 4, 7, 10, 14, 21 | – | Aripiprazole (flexibly dosed 15 to 30 mg/day) | Placebo |  | ||
CN138-074 (El Mallakh et al. 2010) | 3 | Baseline Days 7, 10, 14, 21 | – | Aripiprazole (fixed dose 15 or 30 mg/day) | Placebo |  | ||
CN138-008 (Vieta et al. 2005) | 12 | Baseline Days 4, 7, 10 Weeks 2, 3, 4, 5, 6, 8, 10, 12 | International, multicenter, double-blind, active-controlled study in subjects with bipolar I disorder experiencing acute manic or mixed episodes | ≥20 | – | Aripiprazole (flexibly dosed 15 to 30 mg/day) | Haloperidol (5 to 15 mg/day) |  |
CN138-135 (Keck et al. 2009) | 12 | Baseline Days 2, 4, 7 Weeks 2, 3, 4, 5, 6, 8, 10, 12 | International, multicenter, double-blind, active- and placebo-controlled study in subjects with bipolar I disorder experiencing acute manic or mixed episodes | ≥20 at screening and baseline with <25% decrease between visits | ≤17 at screening and baseline with <4-point increase between visits | Aripiprazole (flexibly dosed 15 to 30 mg/day) | Placebo (to week 3 only) | Lithium (900 to 1,500 mg/day) |
CN138-162 (Young et al. 2009) | 12 | Baseline Days 2, 4, 7, 10 Weeks 2, 3, 4, 5, 6, 8, 10, 12 | Aripiprazole (flexibly dosed 15 to 30Â mg/day) | Placebo (to week 3 only) | Haloperidol (5 to 15Â mg/day) | |||