Event Abstract

Back to Event

EFFICACY AND SAFETY OF LURASIDONE IN CHILDREN AND ADOLESCENT PATIENTS WITH BIPOLAR DEPRESSION

Melissa Delbello1, Robert Goldman2, Ling Deng2, Josephine Cucchiaro2*, Andrei Pikalov2 and Antony Loebel2
  • 1 University of Cincinnati College of Medicine, United States
  • 2 Sunovion (United States), United States

Aims: To evaluate the efficacy and safety of lurasidone in children and adolescent patients with bipolar depression. Methods: Patients ages 10-17 years of age with a DSM-IV-TR diagnosis of bipolar I depression were randomized to 6 weeks of double-blind treatment with once-daily, flexible doses of 20-80 mg. Primary and key secondary endpoints were change from baseline to week 6 in the Children Depression Rating Scale, Revised (CDRS-R) total score, and the Clinical Global Impressions, Bipolar Severity of Depression Score (CGI-BP-S-dep), respectively, evaluated by mixed model repeated measures analysis. Results: A total of 347 patients were randomized and received at least one dose of study medication: lurasidone, N=175 (mean age, 14.2 years; mean CDRS-R, 59.2; completers, 92.0%); and placebo, N=172 (mean age, 14.3 years; mean CDRS-R, 58.6; completers,89.7%). Lurasidone was associated with significant improvement at week 6 vs placebo on the CDRS-R (-21.0 vs -15.3; P<0.0001; effect size, 0.45), and on the CGI-BP-S-dep (-1.49 vs. -1.05; P<0.0001; effect size, 0.44). The 3 most frequent adverse events reported for lurasidone vs. placebo were nausea (16% vs. 6%), somnolence (11% vs. 6%), and increased weight (7% vs. 2%). Lurasidone was associated with no increases in fasting glucose or lipids; and minimal increase in mean weight vs placebo (+0.74 kg vs. +0.44 kg). Conclusions: In children and adolescents with bipolar depression, 6-weeks of placebo-controlled treatment with lurasidone (20-80 mg/d) demonstrated statistically significant and clinically meaningful improvement in measures of depression severity (CDRS-R, CGI-BP-S). In this study, lurasidone was generally well-tolerated and was associated with few effects on weight and metabolic parameters.

Acknowledgements

Clinicaltrials.gov identifier: NCT02046369
Sponsored by Sunovion Pharmaceuticals Inc.

References

Loebel, A., Cucchiaro, J., Silva, R., Kroger H., Hsu, J., Sarma, K., Sachs, G. (2014) Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 171, 160-8. doi: 10.1176/appi.ajp.2013

Ketter, T.A., Sarma, K., Silva, R., Kroger, H., Cucchiaro, J., Loebel, A. (2016) Lurasidone in the long-term treatment of patients with bipolar disorder. Depress Anxiety. 33. 424-34. doi: 10.1002/da.22479

Keywords: Major Depressive Disorder, Adolescent, atypical antipsychotics, lurasidone, randomized clinical trial, Bipolar Disorder

Conference: ISAD LONDON 2017: Perspectives on Mood and Anxiety Disorders: Looking to the future, London, United Kingdom, 6 Jul - 7 Jul, 2017.

Presentation Type: Oral

Topic: Mood disorders in children and adolescents

Citation: Delbello M, Goldman R, Deng L, Cucchiaro J, Pikalov A and Loebel A (2019). EFFICACY AND SAFETY OF LURASIDONE IN CHILDREN AND ADOLESCENT PATIENTS WITH BIPOLAR DEPRESSION. Front. Psychiatry. Conference Abstract: ISAD LONDON 2017: Perspectives on Mood and Anxiety Disorders: Looking to the future. doi: 10.3389/conf.fpsyt.2017.48.00028

Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters.

The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated.

Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed.

For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions.

Received: 26 May 2017; Published Online: 25 Jan 2019.

* Correspondence: Dr. Josephine Cucchiaro, Sunovion (United States), Marlborough, United States, Med23577532@gmail.com