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

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.