Abstract
Minimal long-term benefit: Risk data are available regarding antipsychotic treatments for schizophrenia in pediatric populations. This study evaluated the long-term safety, tolerability, and effectiveness of lurasidone in adolescents with schizophrenia. Patients aged from 13 to 17 who completed 6weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL), flexible dose (20-80mg/day) lurasidone treatment study. Safety was assessed via spontaneous reporting, rating scales, body weight measurement, metabolic, and prolactin testing. Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total score. About 271 patients completed 6weeks of DB treatment and entered the 2-year OL extension study. Altogether, 42.4% discontinued prematurely, 10.7% due to adverse events. During OL treatment, the most common adverse events were headache (24.0%); anxiety (12.9%), schizophrenia, and nausea (12.5%); sedation/somnolence (12.2%); and nasopharyngitis (8.9%). Minimal changes were observed on metabolic parameters and prolactin. Mean change from DB baseline in weight at week 52 and week 104 was +3.3kg and+4.9kg, respectively, compared to an expected weight gain of +3.4kg and+5.7kg, respectively, based on the sex- and age-matched US Center for Disease Control normative data. Continued improvement was observed in PANSS total score, with mean change from OL baseline of -15.6 at week 52 and -18.4 at week 104. In adolescents with schizophrenia, long-term lurasidone treatment was associated with minimal effects on body weight, lipids, glycemic indices, and prolactin. Continued improvement in symptoms of schizophrenia was observed over 2years of lurasidone treatment.
Highlights
IntroductionBecause the vast majority of patients with schizophrenia require chronic treatment, long-term safety and tolerability are paramount considerations when choosing an antipsychotic agent
A combined total of 285 adolescents completed the 6-week, DB, placebo-controlled trial, of whom 271 patients (95.1%) provided informed consent/assent and continued into the current OL extension study, including 181 patients initially randomized to lurasidone (40 mg/d or 80 mg/d) and 90 patients initially randomized to placebo (Figure 1)
The mean daily dose of lurasidone averaged across the 104-week OL treatment period was 57.0 mg/d
Summary
Because the vast majority of patients with schizophrenia require chronic treatment, long-term safety and tolerability are paramount considerations when choosing an antipsychotic agent. This is especially true in adolescents, a vulnerable population at higher risk for experiencing adverse effects from antipsychotics.[12,13,14,15,16,17]. Long-term lurasidone treatment was associated with minimal effects on body weight, lipids, glycemic indices, and prolactin. Continued improvement in symptoms of schizophrenia was observed over 2 years of lurasidone treatment
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