Abilify (aripiprazole), which has long been FDA-approved for both schizophre- nia and manic episodes of bipolar disorder, was recently approved for aug- mentation of antidepressants in patients with treatment-resistant depression. But there has been controversy about the degree of efficacy for mood disorders. A recent meta-analysis examined this issue by looking at all the available placebo- controlled trials of Abilify as adjunctive therapy for depression, as monotherapy for manic and mixed phases of bipolar disorder, and as monotherapy for bipolar depression (an indication for which it is not FDA approved). For adjunctive treat- ment of depression, Abilify yielded about a 10% advantage in remission rate, which was statistically significant. Across five studies examining the treatment of mixed or manic states, Abilify yielded an overall response rate that was significant- ly higher than placebo (about 50% vs. about 35%). Two trials found that Abilify was no better than placebo as monother- apy for bipolar depression. Abilify’s most bothersome side effect in these trials was akathisia. In the antidepressant augmen- tation trials, akathisia occurred in about 25% of depressed patients (average dose 11.5 mg of Abilify), compared to about 4% of patients on placebo; akathisia was reported in about 15% of patients taking an average dose of 25-30 mg of Abilify for manic or mixed states vs. about 4% on placebo (Arbaizar B et al., Gen Hosp Psychiatry 2000;31:478-483). The authors noted that two additional studies for mania and three trials for bipolar depression are marked as completed in a clinical trials registry but have not yet been published, suggesting the possibili- ty of publication bias (the results of these studies have not been revealed by the companies sponsoring the trials). Further, one study with negative results for mania remains unpublished.
TCPR's Take: The bottom line is that the published data suggest Abilify monotherapy is effective for mania or mixed states, but its effect as adjunctive treatment for unipolar depression is small and it is probably ineffective for bipolar depression.
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