Descriptive analysis of the Aripiprazole arm in the Risperidone long-acting injectable vs. Quetiapine relapse prevention trial (constaTRE)

Abstract

Objective: In the this open-label, randomized, relapse prevention trial (ConstaTRE) risperidone long-acting injectable (RLAI) has been compared vs. oral quetiapine and aripiprazole. Here we report the descriptive analysis of this aripiprazole arm. Methods: Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or an oral conventional neuroleptic were randomized to treatment with RLAI or quetiapine or aripiprazole. Efficacy and tolerability were monitored for up to 24 months of treatment. Results: 45 patients were treated with aripiprazole 10–30mg/day. Relapse occurred in 27.3% aripiprazole and 16.5% RLAI treated patients. Estimated mean time-to-relapse among subjects experiencing a relapse was 147.7±116.3 days for aripiprazole and 244.9±208.0 days for RLAI patients. Full remission as defined by Andreasen et al. was achieved by 34.1% aripiprazole and 51.1% RLAI patients and maintained until the end of the trial by 86.7% aripiprazole and 86.2% RLAI patients. CGI-change favored RLAI (-0.55±1.25) vs. aripiprazole (0.03±1.23). Weight gain, extrapyramidal adverse events (AEs), and possibly prolactin-related AEs were more common in RLAI group, gastrointestinal disorders were more common in the aripiprazole arm. Conclusions: In the present study on stable patients with schizophrenia or schizoaffective disorder time-to-relapse was shorter in aripiprazole as compared to RLAI treated patients. This study was supported by Janssen-Cilag GmbH, Neuss, Germany