drugset / Trial / NCT01932541

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

NCT01932541

Phase 4 Withdrawn Massachusetts General Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-01
Primary completion
2018-07
Completion
2018-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule 20 mg Oral
Subject Lurasidone Small molecule 120 mg Oral