Journal of the American Academy of Child and Adolescent Psychiatry
Journal of the American Academy of Child and Adolescent Psychiatry
3 years ago

Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study

To evaluate the efficacy and safety of lurasidone in children and adolescents with bipolar depression. Method Patients 10-17 years with a DSM-5 diagnosis of bipolar I depression were randomized to 6 weeks of double-blind treatment with flexible doses of lurasidone 20-80 mg/day. The primary endpoint was change from baseline to week 6 in the Children’s Depression Rating Scale–Revised (CDRS-R) total score, evaluated by a mixed model repeated measures analysis. Results A total of 347 patients were randomized and received at least one dose of lurasidone (n=175; mean age, 14.2 years; mean dose, 33.6 mg/day) or placebo (n=172; mean age, 14.3 years). At the primary week 6 endpoint, treatment with lurasidone was associated with statistically significant improvement compared with placebo in CDRS-R total score (-21.0 vs. -15.3; P<.0001; effect size, 0.45). Lurasidone was also associated with statistically significant improvement in the Clinical Global Impression-Bipolar-Severity (key secondary measure), and measures of anxiety, quality of life, and global functioning. Study completion rates were 92.0% in the lurasidone group, and 89.7% in the placebo group; discontinuation rates due to adverse events were the same for both groups (1.7%). The two most common adverse events on lurasidone were nausea and somnolence. Treatment with lurasidone was associated with few effects on weight and metabolic parameters. Conclusion In this placebo-controlled study, monotherapy with lurasidone, in the dose range of 20-80 mg/day, significantly reduced depressive symptoms in children and adolescents with bipolar depression. Lurasidone was well-tolerated, with minimal effects on weight and metabolic parameters.

Publisher URL: www.sciencedirect.com/science

DOI: S0890856717317720

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