Safety and Effectiveness of Lurasidone in Adolescents with Schizophrenia
An open-label extension of a placebo-controlled study involving 271 patients aged 13–17 years with schizophrenia showed minimal impact on body weight, lipid levels, prolactin, and blood glucose during 2 years of treatment while maintaining and deepening the alleviation of schizophrenia symptoms.
Study Methodology and Progress
The aim of the study was to evaluate the safety and tolerability of lurasidone in adolescent patients with schizophrenia. Individuals aged 13–17 who completed a 6-week double-blind, placebo-controlled phase of the study were included. Under open-label conditions, they continued taking lurasidone at a flexible dose of 20–80 mg/day.
Efficacy was assessed based on PANSS (Positive and Negative Syndrome Scale) scores, and safety was measured through spontaneously reported adverse events, rating scales, body weight measurements, and laboratory tests.
Results
During the open-label phase, 42.4% of patients discontinued treatment, 10.7% of whom did so due to adverse events. The most common adverse event was headache (24.0% of patients), followed by anxiety (12.9%), nausea (12.5%), sedation or somnolence (12.2%), and nasopharyngitis (8.9%).
Median body weight increased by 3.3 kg after 1 year and by 4.9 kg after 2 years, which is less than the increase expected based on normative data from the U.S. Centers for Disease Control and Prevention (CDC) for a population of equivalent age and sex (+3.4 kg and +5.7 kg, respectively). Metabolic parameters and prolactin levels changed minimally during lurasidone treatment.
The authors observed sustained efficacy with a decrease in PANSS scores from the double-blind phase entry by 15.6 points after 1 year and by 18.4 points after 2 years of lurasidone treatment.
Conclusion
Lurasidone can be considered an effective and safe treatment for adolescent patients with schizophrenia according to the most recent findings.
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Source: Correll C. U., Findling R. L., Tocco M. et al. Safety and effectiveness of lurasidone in adolescents with schizophrenia: results of a 2-year, open-label extension study. CNS Spectr 2020 Oct 20: 1–11, doi: 10.1017/S1092852920001893 [Epub ahead of print].
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