The efficacy of aripiprazole in the maintenance treatment of bipolar disorder has been addressed by a 26-week randomized trial in 161 patients (published as an abstract). These data show a significantly superior effect of aripiprazole versus placebo in the prevention of relapse following a manic episode.

Strengths

• Well-documented efficacy in acute mania (2 positive studies of acute mania and 1 unpublished negative study).
• Less weight gain, hormonal changes, and EPS compared with other atypical antipsychotics i.e., 'a different path to success'.

Weaknesses

• Limited data available in bipolar maintenance.
• No evidence for maintenance efficacy in bipolar depression.

GSK Counterclaim:

• Not shown to reduce the time to a depressive relapse or the number of depressive relapses.

Supporting trials