Long-term Efficacy of Lurasidone in Antipsychotic-Naive vs. Antipsychotic-Exposed Adolescents with Schizophrenia: Post-hoc Analysis of a Two Year, Open-label Study

Background: The aim of this post-hoc analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naïve adolescents with schizophrenia.

Methods: Patients aged 13-17 years with schizophrenia, and a PANSS total score ≥70 and  < 120, were randomized to 6 weeks of double-blind (DB) treatment with lurasidone (40 or 80 mg/day) or placebo. Completers were treated with lurasidone (20-80 mg/d) in a 2-year open-label (OL) extension study. Efficacy was evaluated for 2 patient groups based on prior treatment status (treatment naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment. Efficacy measures included the PANSS total score.

Results: A total of 50 TN and 221 TP patients completed the 6-week DB study and entered the extension study; and 30 (60.0%) TN and 126 (57.0%) TP patients completed 104 weeks. During the initial 6 weeks of DB treatment, mean change in PANSS total score at endpoint was greater for lurasidone vs. placebo in both the TN (-25.0 vs. -14.4; P < 0.02; effect size, 0.75) and TP (-17.3 vs. -10.0; P < 0.001; ES, 0.45) groups. During OL extension phase treatment with lurasidone, mean change from DB baseline in the PANSS total score for TN and TP patients, at week 52 was -32.6 and -28.1, respectively; and at week 104 was -33.6 and -29.2, respectively.

Discussion: In this post-hoc analysis of a 2-year study, adolescents with schizophrenia who had received no previous antipsychotic therapy showed greater improvement compared to previously treated patients during both short- and long-term treatment with lurasidone.