NCT02046369

Lurasidone Pediatric Bipolar Study

A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a randomized, parallel, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of flexibly dosed lurasidone (20 - 80 mg/day) for 6 weeks compared with placebo in children and adolescent subjects with depression associated with Bipolar I Disorder (bipolar depression).

Conditions

• Bipolar I Depression

Interventions

Type	Name	Description
DRUG	Lurasidone	Lurasidone flexibly dosed 20-80 mg once daily
DRUG	Placebo	Placebo Comparator once daily

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-01-27
• Last updated: 2017-12-20
• Results posted: 2017-12-20

Locations

66 sites across 11 countries: United States, Bulgaria, Colombia, France, Hungary, Mexico, Philippines, Poland, Puerto Rico, South Korea, Ukraine