For patients with schizophrenia, discontinuation of antipsychotic medication is by far the most important reason for relapse. A possible method to optimize medication adherence is to treat patients with long-term, depot medication rather than oral medication.
This is a pragmatic open label, randomized, multicenter, multinational study including inpatients and outpatients meeting diagnostic criteria for schizophrenia disorder according to DSM-IV-R. Our primary objective is to compare all cause discontinuation rates in patients with schizophrenia randomized to either one of the two depot medications (aripiprazole depot or paliperidone palmitate) with patients randomized to either one of the two oral formulations of the same medication (aripiprazole or paliperidone) over an 18 month follow-up period.
Secondary objectives include differences in symptom severity, global functioning, quality of life, psychosocial functioning, side-effects, safety measures, as well as associations between immune parameters and these outcome measures. In addition, the a-priori opinion of the patients and investigators regarding the comparative values of oral vs. depot medication is assessed.
The study is funded by the European Group for Research in Schizophrenia and is performed in collaboration with partners across Europe. Inclusion began in 2015 and the study is expected to conclude in 2020.