Abstract
BACKGROUND: Functional impairment affects many patients with schizophrenia. Treatment with the long-acting injectable antipsychotic aripiprazole once-monthly (AOM) may help improve functioning. OBJECTIVES: To explore changes in functioning in patients with schizophrenia who received AOM treatment in observational studies. METHODS: Here we report functional outcomes in the form of Global Assessment of Functioning (GAF) scores in a pooled analysis of data from two observational studies from Canada (NCT02131415) and Germany (vfa non-interventional studies registry 15960N). Data from 396 patients were analyzed. RESULTS: At baseline, the mean GAF score was 47.7 (SD 13.4). During 6 months of treatment with AOM, the mean GAF score increased to 59.4 (SD 15.8). Subgroups stratified by patient age (≤35 years/>35 years), sex, disease duration (≤5 years/>5 years) and disease severity at baseline had all significantly improved their GAF at month 6. 51.5% of the patients showed a GAF score increase of at least 10 points, which was regarded as clinically meaningful, and were considered responders. CONCLUSIONS: These data show that treatment with AOM may help improve patient functioning in a routine treatment setting. TRIAL REGISTRATION: NCT02131415 (May 6, 2014), vfa non-interventional studies registry 15960N.