Authors: Keck PE, et al.
Title: A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania.
Reference: Am J Psychiatry 2003;160:1651-8. 
Purpose: To compare the efficacy and safety of aripiprazole with placebo for the treatment of patients in an acute manic or mixed episode of bipolar disorder. 
Study design: Randomized, double-blinded, placebo-controlled, multicenter study. 
Follow up: 3 weeks. 
Patients: 262 patients (130 aripiprazole, 132 placebo).
Treatment: Aripiprazole 30 mg/day (reduced to 15 mg/day if needed for tolerability). 
Results: There were significant mean improvements in total YMRS score with aripiprazole compared with placebo. There was also a higher response rate (40% versus 19%) and completion rate (42% versus 21%) with aripiprazole compared with placebo.  Aripiprazole was safe and well tolerated.