Objective: To obtain long-term data on the safety and effectiveness of lurasidone in adolescents with schizophrenia
Methods: Adolescents (13-17 years) who completed 6 weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL) extension study in which patients were continued on lurasidone 20-80 mg/d or switched from placebo to lurasidone. Efficacy measures included the Positive and Negative Syndrome Scale (PANSS) total score (responder criteria, ≥20% reduction from DB baseline).
Results: A total of 271 patients entered the 2-year extension study, of whom 42.4% discontinued prematurely. Mean PANSS total score was 93.5 at DB baseline, and 76.0 at OL Baseline. Mean change from DB baseline in the PANSS total score at weeks 52 (n=189) and 104 (n=156) was -32.4 and -34.3, respectively. Responder rates at weeks 52 and 104 were 92.1% and 91.0%, respectively. During OL treatment, the most common adverse events were headache (24.0%); and schizophrenia, anxiety and nausea (12.5%). Median change in laboratory parameters from DB baseline to weeks 52 and 104, respectively, were: total cholesterol, -3.0 and +5.0 mg/dL; triglycerides, +11.0 and +14.0 mg/dL; and hemoglobin A1c, 0.0 and 0.0%. Mean change from DB baseline in weight at week 52 and week 104 was +3.3 kg and +5.0 kg, respectively (vs. expected weight gain: +3.4 kg and +5.7 kg, respectively, based on CDC growth charts).
Conclusion: In adolescents with schizophrenia, long-term treatment with lurasidone was associated with continued improvement in symptoms of schizophrenia; minimal effects were observed on weight, lipids, and glycemic indices.