Abstract: Background: Selecting the first antipsychotic agent after a first episode of psychosis (FEP) is a critical task that may impact on the long-term outcome of the disease. Many randomized clinical trials (RCTs) have compared oral second-generation antipsychotics (SGAs) for the treatment of acute symptoms of schizophrenia spectrum disorders (SSDs), while fewer studies are available for long-term maintenance treatment. As far as we are concerned, this is the first study comparing head-to-head the effectiveness of aripiprazole and risperidone, two of the most widely used SGAs, for the long-term treatment after a first episode of psicosis. Aim of the study: The aim of this study was to compare the effectiveness of aripiprazole and risperidone for the long-term treatment after a FEP. In shed of previous data from our group obtained along prior stages of the disease (6-week and 12-week follow-up), we hypothesized the non-inferiority of aripiprazole compared to risperidone in terms of effectiveness for the long-term treatment of SSD after a FEP. Methods: From February 2011 to October 2018, a prospective, open-label, RCT was undertaken in Hospital Universitario Marqués de Valdecilla (Santander, Spain) inpatient and outpatient units. Two hundred-sixty-six FEP, drug-naïve SSD patients were randomly assigned to aripiprazole (n = 136), or risperidone (n = 130) and followed-up for one year. The primary effectiveness measures were all-cause treatment discontinuation rate and mean time until all-cause treatment discontinuation. Analyses were performed following intention-to-treat principles. Results: A total of 158 patients (59.4%) discontinued treatment by the end of 1-year follow-up. Statistically significant differences (X2 = 13.632; p = 0.000) were observed between all-cause discontinuation (N = 66; 48.5%) favoring the aripiprazole group compared to the risperidone group (N = 92; 70.8%). Nonetheless, Kaplan Mayer survival analysis regarding mean time until all-cause discontinuation did not result in statistically significant differences between treatment groups but again in a trend towards significancy favoring the aripiprazole group (p= 0.0068). Adverse effects were the main reason for discontinuation during the 1-year follow-up period (N = 48; 18%). In this sense, statistically significant differences (X2 = 13.551; p = 0.000) were found between patients under risperidone treatment (N = 13; 9,6%) and patients under aripiprazole treatment (N = 35; 26,9%) regarding the burden of adverse effects as the main reason for discontinuation. We found no significant differences on the remaining reasons considered for discontinuation (insufficient efficacy, non-compliance, and other causes). Nevertheless, there was a trend toward statistical significance regarding noncompliance (5.1% (N = 7) favoring the aripiprazole group over 11.5% (N = 15) the risperidone group). Conclusions: Patients under aripiprazole treatment were less likely to discontinue antipsychotic treatment due to any reason during the first-year follow-up after a FEP. Adverse effects were the main responsible for differences of discontinuation between both treatment groups, being higher in the risperidone group.

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