A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Summary

The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.

Timeline

Start

2008-01

Primary completion

2010-11

Completion

2010-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Aripiprazole vs Placebo; p <0.001; Mean Difference (Final Values) -6.0 (95% CI -9.4 to -2.7); ANCOVA NCT00606281 ↗

Drugs

Indications