Lurasidone Pediatric Bipolar Study

NCT02046369 ↗

Phase 3 Completed 350 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

Timeline

Start: 2014-03
Primary completion: 2016-10
Completion: 2016-10

Outcome

Met primary endpoint

paper treatment with lurasidone was associated with statistically significant improvement compared with placebo in CDRS-R total score (-21.0 versus -15.3; p < .0001; effect size 0.45). PMID 29173735 ↗

registry analysis (superiority test); Luradisone vs Placebo; p <0.0001; LS mean differnce (SE) -5.7 (95% CI -8.4 to -3.0) NCT02046369 ↗

Publications

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. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1015-1025. doi: 10.1016/j.jaac.2017.10.006. Epub 2017 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	20 mg	—
Subject	Lurasidone	Small molecule	80 mg	—