Tolerability of cariprazine in the early stage of schizophrenia: A pooled, post-hoc analysis of 4 phase ii/iii double-blind placebo-controlled trials

Abstract

Background: To determine the “real world” relapse rate in patients with first-episode psychosis (FEP) who had discontinued antipsychotic medication and identify socio-demographic and clinical factors associated with the risk of relapse. Methods: Quantitative data were obtained via case-note review on 63 patients with FEP who had discontinued antipsychotic medication from Birmingham Early Intervention Service between 2012 and 2015. The follow-up period was until either: an occurrence of a relapse; end of 12-month study period; end of patient's case-note record. Relapse was defined as a return of symptoms requiring one of the following: home treatment, hospital admission or was based on clinical teams’ decision as having a relapse. A pro-forma targeted pre-defined socio-demographic and clinical factors. Survival analysis was undertaken to estimate the 12-month relapse rate following discontinuation of antipsychotics and Cox regression performed to identify relapse predictors. Results: The Kaplan-Meier 12-month relapse estimate was 67% (95% confidence interval, 54%, 80%). Significant factors (P