The Efficacy and Safety of Aripiprazole Once-Monthly 400mg (AOM 400) in African American/Black Patients Compared to Non-African American/Black Patients

Background: Recent analyses have indicated that medical treatment for schizophrenia varies among racial groups.

Methods: Post-hoc analysis from a 12-week, randomized, double-blind, placebo-controlled trial was conducted in patients with schizophrenia who were experiencing an acute psychotic episode (NCT01663532). Patients were randomized to AOM 400 or placebo (PLB). This analysis examined mean differences from baseline on Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance scale (PSP) in African American/Black (AA/B) patients compared to non-AA/B (Caucasian, Asian, native Hawaiian, or other Pacific Islander) patients. Additionally, changes in weight and other metabolic parameters were also examined.

Results: There was a similar pattern of efficacy demonstrated in the AA/B group (n=223) compared to the non-AA/B (n=117) on both the PANSS and PSP from baseline to week 10. The difference in effect in the AA/B group compared to PLB, however, was less than the non-AA/B group. The safety results demonstrated that the AA/B patients had a significant mean weight change from baseline on AOM compared to the B/AA patients on PLB (+4.9 and +0.7, respectively; p<0.0001). This change was not seen in the non-AA/B patients on AOM compared to the non-AA/B patients on PLB (+1.4 and +1.3, respectively, p=0.7942).

Conclusion: There was no difference in efficacy between African American/Black patients and non-African American/Black patients. A difference in weight wasn’t seen in the non-African American/Black group, however more weight gain was seen in the African American/Black group on AOM 400 compared to the PLB patients.