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.
Keywords: early illness; paliperidone palmitate; recently diagnosed; relapse; schizophrenia.
© 2018 The Authors Early Intervention in Psychiatry Published by John Wiley & Sons Australia, Ltd.