Aripirazole as adjunct to a mood stabilizer and citalopram in bipolar depression: A randomized, placebo-controlled study

The use of atypical antipsychotics (AAPs) for the treatment of unipolar and bipolar depression has become more and more common, and aripiprazole showed positive effects in the treatment of unipolar depression. However, so far there have been no placebo-controlled studies of adjunctive aripiprazole for the treatment of bipolar depression. Methods: In this prospective, placebo-controlled and randomized trial, 23 subjects with bipolar depression according to DSM-IV criteria were included. Before randomization, patients had to be on stable mood stabilizer treatment with lithium or valproate. After inclusion, all patients were openly treated with additional citalopram (40mg/day) and with additional aripiprazole (10 to 30mg/day) or placebo for 6 weeks in a double-blind fashion. The primary outcome was the reduction of the Hamilton Depression Scale (HRDS) within 6 weeks. Results: After 6 weeks of treatment, the HDRS score decreased in both groups, at endpoint, the mean HDRS score was 7.3 points in the aripiprazole group and 7.7 points in the placebo group. There was no significant difference between the both groups at any point of time with respect to the HRDS. Conclusion: Derived from this small pilot study, adjunctive aripiprazole does not seem to be a promising strategy for the acute treatment of bipolar depression, although there are positive effects of aripiprazole in unipolar depression in other studies. Considering positive results regarding the efficacy of aripi

This study was supported by Bristol-Myers Squibb (BMS), German Branch