Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, placebo- and lithium-controlled study

Objectives: Evaluate the efficacy and safety of aripiprazole monotherapy as acute and continuation therapy for acute bipolar I mania. Methods: Patients with acute bipolar I mania (Young Mania Rating Scale (YMRS) ≥20), manic or mixed who required hospitalization were randomized to double-blind aripiprazole (15–30mg; n=155), placebo (n=165) or lithium (900–1500mg; n=160) (1:1:1) for 3 weeks. Placebo-treated patients then received double-blind aripiprazole for another 9 weeks; while all other patients remained on the same blinded treatment. Outcome measures included mean change from baseline in YMRS Total score to Week 3 (primary endpoint) and Week 12 (LOCF). Response rate (≥50% improvement in YMRS Total score) was a secondary endpoint. Results: Completion rates were similar between groups. Aripiprazole demonstrated significantly greater improvement from baseline to Week 3 in mean YMRS Total score than placebo (–12.64 vs. –9.01; p<0.001, LOCF). Significant improvement in YMRS Total score was also seen with lithium vs. placebo at Week 3 (–12.03 vs. –9.01; p=0.005, LOCF). Improvements in YMRS Total score were maintained to Week 12 for aripiprazole and lithium (–14.48 and –12.71). Response rates at Week 3 were significantly higher with aripiprazole (46.8%) and lithium (45.8%) than placebo (34.4%; both p<0.05, LOCF); response rate increased to Week 12 with aripiprazole (56.5%) and lithium (49.0%). Most common adverse events with aripiprazole were headache (23.4%), nausea (22.7%)

This study was supported by Bristol-Myers Squibb