Long-term Efficacy of Lurasidone in Antipsychotic-naïve vs. Antipsychotic-exposed Adolescents With Schizophrenia: Post-hoc Analysis of a Two Year, Open-label Study

Background: Few studies have prospectively evaluated short- or long-term antipsychotic efficacy in treatment-naïve (vs. previously treated) first-episode schizophrenia. The aim of this post-hoc analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naïve adolescents with schizophrenia.

Method: Patients aged 13-17 years with schizophrenia who completed 6 weeks of double-blind (DB) treatment with lurasidone or placebo entered a 104 week open-label (OL) study with lurasidone 40-80 mg/d. Efficacy was evaluated for 2 patient groups based on treatment status prior to entering the initial DB study (treatment-naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment prior to randomization. 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. In the ITT population of the DB study, larger lurasidone treatment effects (vs. placebo) were noted at DB endpoint on the PANSS total score in the TN group (-25.0 vs. -14.4; P < 0.02; effect size [ES]=0.75) compared to the TP group (-17.3 vs. -10.0; P < 0.001; ES=0.45). During OL treatment with lurasidone, the magnitude of improvement from DB baseline continued to be somewhat larger in the PANSS total score for TN patients (n=38) vs. TP patients (151) at week 52 (-32.6 vs. -28.1) and week 104 (-33.6 vs. -29.2).

Conclusion: In this 104 week OL study of lurasidone in adolescents with schizophrenia, TN patients achieved greater improvement than TP patients during acute treatment; and this advantage was largely maintained during long-term treatment.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.