drugset / Trial / NCT01731119

Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents

NCT01731119

NaSingle-groupOpen-labelTreatment

Summary

The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.

Timeline

Start
2012-12
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule 20 mg
Subject Lurasidone Small molecule 40 mg
Subject Lurasidone Small molecule 160 mg