Objectives: Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting injectable formulation of aripiprazole licensed in the US, Canada and Australia for maintenance treatment of adults with BP-I. Here we evaluate the effect of long-term AOM 400 maintenance treatment on functioning in BP-I patients from the open-label, long-term safety study.
Method: Post-hoc analyses were conducted on data from the open-label, long-term safety study to evaluate functioning in de novo and roll-over patients who completed the double-blind withdrawal study. The Functioning Assessment Short Test (FAST), was used to evaluate functioning in the domains of autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. FAST total and domain scores were analyzed based on the efficacy sample using descriptive statistics and last observation carried forward.
Results: In the open-label, long-term safety study, FAST total scores were maintained during the 52-week maintenance phase in both de novo and roll over patients with mean changes from baseline of -0.08 (11.90) and 1.07 (12.85), respectively. The FAST domain scores were also maintained during the 52-week maintenance phase, with slight numerical improvements for de novo patients in the domains of occupational functioning, cognitive functioning, financial issues, and interpersonal relationships, and for roll over patients in the domain interpersonal relationships.
Conclusions: In this study, functioning was maintained for de novo and roll over patients with BP-I during 52 weeks of AOM 400 treatment as evaluated using FAST total and domain scores.