Addendum to Clinical Study Report for Study CN138135: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

The acute phase clinical study report (CSR) for CN138135 presented efficacy and safety data of aripiprazole monotherapy relative to placebo or lithium therapy (control) in patients with Bipolar I Disorder, mixed or manic, with or without psychotic features during a 3-week period. The study assessed the efficacy of aripiprazole to placebo at Week 3 and also included maintenance of effect analysis to assess whether the efficacy results seen at Week 3 in both aripiprazole and lithium groups were maintained through Week 12. Superiority of aripiprazole to placebo was demonstrated at Week 3. Further, the efficacy observed at Week 3 in both the aripiprazole group and the lithium group was maintained and was similar in both groups through Week 12. Additionally it was concluded in the acute phase CSR, that aripiprazole was safe and well tolerated. This addendum to the acute phase CSR presents the efficacy and safety data for patients who completed the 12-week double-blind treatment phase and for those whom continued participation in the study was indicated for an additional 40 weeks. The purpose of this report is to present the results of the assessment of the long-term maintenance effect and safety of aripiprazole monotherapy relative to lithium monotherapy in patients with bipolar I disorder.