Objective: We performed meta-analyses to obtain pooled estimates from controlled clinical trials on the efficacy of aripiprazole in major depression disorder and manic phase of bipolar disorder.
Methods: A search was performed in Medline/PubMed using "aripiprazole" AND "depressive disorder" and "aripiprazole" AND "bipolar disorder" as keywords, and "randomized controlled trial" as limit. The last search was performed by April 30, 2009. References in the selected articles were revised to identify other studies. We selected four placebo-controlled clinical trials on aripiprazole's effect on major depression, and three on aripiprazole's effect on bipolar disorder. Studies performed in patients with comorbidity or devoted to measuring the effect of aripiprazole for maintenance therapy were excluded. We extracted, in duplicate, data on number of patients, withdrawals, changes in Montgomery-Asberg Depression Rating Scale and Young Mania Rating Scale (YMRS), response and remission rates, and side effects.
Results: Aripripazole is effective in increasing response rates in depressive patients (response rate in the aripiprazole group minus response rate in the placebo group: 7.7%, 95% CI: 1.5-14.2) and manic patients (difference in response rates: 15.7%, 95% CI: 9.7-21.8). It also improves by 3 points the scores in YMRS. Evidence of improving remission rates is unavailable. Some side effects were more frequent in patients taking aripiprazole; this was the case of akathisia, especially in depressive trials (rate difference: 20.3%, 95% CI: 16.9-23.7), and nausea in manic patients (rate difference: 10.5%, 95% CI: 7.4-13.5). Insomnia and restlessness were also more frequent in depressive patients taking aripiprazole.
Conclusion: We found evidence suggesting that aripiprazole is effective in both depressive and manic patients, but has relevant side effects. Further research is needed to identify its benefits for comorbid patients and its long-term effect.