BACKGROUND: Major treatment failures (MTF), such as psychiatric hospitalization and arrest/incarceration, are associated with substantial economic and societal burden, especially for persons with recent-onset schizophrenia.
METHODS: DREaM (NCT02431702), a randomized, open-label study, compared treatment failure with paliperidone palmitate (PP) versus oral antipsychotics (OAPs) in recent-onset schizophrenia, using a 3-phase design: Part I, 2-month oral run-in; Part II, 9-month disease progression phase (OAP or PP); Part III, 9 months of additional treatment (PP/PP; OAP re-randomized: OAP/OAP or OAP/PP). PP/PP and OAP/OAP comprised the 18-month extended disease progression (EDP) phase. This post hoc analysis examined differences in time to first MTF (TtFMTF) between PP and OAP.
RESULTS: During Part II, 12.8% of participants in the PP group and 13.4% in the OAP group experienced MTF; there was no statistically significant difference in TtFMTF between groups (P=0.918). During the EDP phase, 10.2% of participants in the PP/PP group and 25.4% in the OAP/OAP group experienced MTF; the difference in TtFMTF was statistically significant (P=0.045, NNT=7). During Part III, no participants in the PP/PP group, 3.5% in the OAP/PP group, and 15.9% in the OAP/OAP group experienced MTF; the difference in TtFMTF among groups was statistically significant (P=0.002).
CONCLUSIONS: A large study effect due to inherent biases associated with study participation was observed in Part I that persisted for the trial‚Äôs duration. Nevertheless, with longer treatment, the differences between groups became significant for TtFMTF in favor of PP, suggesting greater effectiveness of PP compared with OAPs as measured by key public health treatment events.