Effectiveness and safety of long-acting aripiprazole 960 mg: preliminary findings from a prospective real-world observational study

Poor treatment adherence is a major challenge in the management of severe mental disorders, as it is associated with an increased risk of relapse, rehospitalization, symptom worsening, treatment resistance, and all-cause mortality. In 2023 a 2-month 960 mg formulation of aripiprazole 2 months ready-to-use (Ari 2MRTU) was introduced. Compared with monthly long-acting injectable (LAI) drugs, Ari 2MRTU may improve adherence and patient satisfaction by reducing the frequency of healthcare visits. The aim of this prospective longitudinal study was to provide preliminary real-world data on the effectiveness, safety, and acceptability of Ari 2MRTU. Fifty patients, most of whom had previously received aripiprazole, were assessed at baseline, 2 months, and 4 months. Data regarding effectiveness, safety, and acceptability outcomes were collected. Psychometric scores changes were analyzed employing linear mixed-effect regression models accounting for time, age, sex, and previous oral treatment with aripiprazole. Our preliminary findings suggest that Ari 2MRTU is associated with improvements in psychotic symptoms over time, while changes in affective symptoms were less consistent. The findings were also consistent with an overall favorable tolerability profile of Ari 2MRTU. Although adverse events were commonly reported, no unexpected safety signals emerged during the follow-up period, and patients’ attitudes toward LAI treatment generally improved over time.