Paliperidone palmitate once-every-3-months in adults with early illness schizophrenia

Aim This post hoc analysis of a double-blind (DB), randomized, placebo-controlled, relapse-prevention study evaluated the effects of paliperidone palmitate once-every-3-months (PP3M) in a subpopulation of adults with early illness schizophrenia (duration <= 5 years) from a clinical trial. Methods Patients received either PP3M or placebo every 3 months in the DB phase. The primary efficacy variable was time from randomization to first relapse. Symptom severity, patient functioning, and safety were also assessed. Results A total of 119 patients who entered the DB phase met the criteria for early illness schizophrenia (PP3M, n = 62; placebo, n = 57). PP3M significantly delayed time to relapse vs placebo (P = .035; hazard ratio, 3.08; 95% CI, 1.08-8.80). Symptomatic control and patient functioning were maintained in the PP3M group but significantly worsened in the placebo group. There were no unexpected tolerability findings. Conclusions PP3M reduced relapse risk and maintained symptomatic and functional improvements compared with placebo in patients with early illness schizophrenia.