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Psych Congress  

Effectiveness of Lurasidone in Adolescents With Schizophrenia: Interim Analysis at Week 52 of a 24-Month, Open-Label Extension Study

Michael Tocco, PhD; Christoph Correll, MD; Robert Goldman, PhD; Josephine Cucchiaro, PhD; Ling Deng, PhD; Antony Loebel, MD
Sunovion Pharmaceuticals Inc.

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Objective: The aim of this interim analysis was to obtain data on the long-term effectiveness of lurasidone in adolescents with schizophrenia.

Methods: Patients aged 13-17 years old with schizophrenia who completed a 6-week, double-blind (DB), placebo-controlled lurasidone treatment study were eligible for enrolment in a 24-month, open-label (OL) study of lurasidone 20-80 mg/day (placebo patients were switched to lurasidone). Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total and positive and negative subscale scores.

Results: A total of 271 patients (mean age, 15.6 years) were enrolled; the mean dose of lurasidone was 56.6 mg/d. Initial improvement in the extension phase cohort (at the end of 6 weeks of double-blind treatment), was greater with lurasidone (N=181) compared with placebo (N=90) on the PANSS total score (DB baseline mean: 93.9 vs. 92.7; OL baseline mean: 74.1 vs. 79.8). Responder rates for patients who continued on lurasidone in the OL phase vs. those who switched from placebo to lurasidone, were 70.2% vs. 48.9% at OL Baseline, 88.3% vs. 100% at Week 52 (observed case; OC), and 82.5% vs. 83.3% at Week 52 (LOCF). For all lurasidone patients combined, the mean change at Week 52 (OC and LOCF, respectively) was as follows: PANSS total score (-14.8 and -9.3), PANSS positive subscale score (-4.5 and -2.9), and negative subscale score (-3.4 and -2.1).

Conclusion: Long-term treatment with lurasidone was associated with sustained improvement in psychotic symptoms in this week 52 interim analysis of a 24-month extension study in adolescents with schizophrenia.

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