Lurasidone safely improved depressive symptoms in children and adolescents with bipolar disorder I, according to the results of a study published in Journal of the American Academy of Child & Adolescent Psychiatry.
To evaluate the safety and efficacy of lurasidone monotherapy in children with bipolar depression, 347 patients ages 10 to 17 years were randomly assigned to receive lurasidone in a range of 20 to 80 mg/day or placebo over 6 weeks. The change in depression from baseline was measured with the Children’s Depression Rating Scale-Revised.
At 6-week follow-up, children treated with lurasidone had significantly improved depression scores from baseline compared with placebo (-21.0 vs -15.3; P <.001). Similarly, lurasidone-treated patients had improvements in Clinical Global Impression-Bipolar-Severity scores (-1.49 vs -1.05; P <.001). For both measures, the improvements from baseline were significantly better than placebo by week 2.
When stratified by age, patients who were 10- to 14-years-old had a smaller mean difference in score compared with those who were 15- to 17-years-old (-1.8 vs -8.6; P <.05). The researchers attributed this in part to a greater improvement in scores among the placebo group at 6 weeks for those age 10 to 14 years.
Discontinuation rates did not differ between groups (1.7% for both). For the lurasidone group, the most common adverse events were nausea and somnolence.
The researchers concluded that lurasidone “was associated with statistically significant and clinically meaningful improvement in depressive symptoms” and was well tolerated, “with notably low rates of akathisia and extrapyramidal symptoms.”
DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and safety of lurasidone in children and adolescents with bipolar I depression: a double-blind, placebo-controlled study [published online October 13, 2017]. J Am Acad Child Adolesc Psychiatry. doi:10.1016/j.jaac.2017.10.006