NCT01932541

Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old

Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old With Bipolar I, Bipolar II and Bipolar Spectrum Disorder

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders. We hypothesize that Lurasidone will be safe, tolerable, and effective in improving the core symptoms of bipolar disorders in children and adolescents ages 6-17.

Conditions

• Mania
• Bipolar I
• Bipolar II
• Bipolar Spectrum Disorder
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Latuda (Lurasidone)	Latuda® (lurasidone) tablets taken by mouth once daily, between 20 mg and 120 mg a day.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2013-08-30
• Last updated: 2018-07-20

Locations

1 site across 1 country: United States