Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study.

ABSTRACT: To evaluate the efficacy and safety of lurasidone in acutely symptomatic adolescent patients with schizophrenia.Patients aged 13-17 years were randomly assigned to 6 weeks of double-blind, fixed-dose lurasidone (40 or 80?mg/day) or placebo. Primary and key secondary efficacy measures were change from baseline to week 6 in the Positive and Negative Symptom Scale (PANSS) total score and Clinical Global Impressions-Severity (CGI-S) score, respectively, using mixed model for repeated measurement (MMRM) analysis. The proportion of patients achieving treatment response at endpoint, based on ?20% reduction in PANSS total score, was analyzed using a logistic regression model.Least-squares (LS) mean change in PANSS total score from baseline to week 6 was -18.6 with lurasidone 40?mg/day (N?=?108; p?

SUBMITTER: Goldman R 

PROVIDER: S-EPMC5568017 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature