PRIDE: Monthly injection delayed schizophrenia relapse
Data presented at the American Psychiatric Association Annual Meeting demonstrate that once-monthly paliperidone palmitate injections were superior to daily treatment with oral antipsychotics for the treatment of patients with schizophrenia with a history of incarceration.
The Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study included 444 patients who were randomly assigned to monthly paliperidone palmitate (Invega Sustenna, Janssen) injection (n=226) or oral daily antipsychotics (n=218). Time to treatment failure was the primary endpoint and was defined as arrest/incarceration, psychiatric hospitalization, suicide, treatment discontinuation or supplementation due to inefficacy, safety/tolerability or increased services to prevent psychiatric hospitalization.
The median time to treatment failure was 416 days among patients in the injection group and 226 days among those in the oral antipsychotic group.
The most common adverse events in the injection group were pain at the injection site (18.6%), insomnia (16.8%), weight gain (11.9%), akathisia (11.1%) and anxiety (10.6%).
More than half of the participants (59.5%) were substance abusers; the median time to treatment failure in this group was 260 days but could not be discerned in the group of non-substance abusers.
Among patients with schizophrenia with a history of incarceration, researchers concluded that paliperidone palmitate significantly delayed treatment failure.
Disclosure: The study was supported by Janssen Scientific Affairs